FDA Approvals of Brand-Name Prescription Cancer Drugs in 2017

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates

The cancer drugs included in this review were approved for the first time or received additional approvals by the US Food and Drug Administration in 2017 and are grouped here by several categories:

  1. New Molecular Entities and New Biologic License Applications
  2. New Gene Therapies and Blood Products
  3. New Indications, New Combinations, and New Biosimilars
  4. New Dosages, Dosage Forms, Formulations, and Patient Populations

I. New Molecular Entities and New Biologic License Applications

Aliqopa (NME)
Copanlisib – Bayer HealthCare
  • Class/route Phosphatidylinositol-3-kinase inhibitor; intravenous injection
  • Indication For treatment of adults with relapsed follicular lymphoma who received ≥2 systemic therapies
  • Approval considerations Accelerated approval, fast track, priority review, orphan drug
  • Approval date September 14, 2017
Alunbrig (NME)
Brigatinib – Takeda Oncology
  • Class/route Tyrosine kinase inhibitor; oral tablets
  • Indication For treatment of patients with ALK-positive metastatic NSCLC whose disease progressed with crizotinib or who are intolerant to crizotinib
  • Approval considerations Accelerated approval, breakthrough therapy, priority review, orphan drug
  • Approval date April 28, 2017
Bavencio (BLA)
Avelumab – EMD Serono/Pfizer
  • Class/route PD-L1–blocking antibody; intravenous injection
  • Indication For treatment of all patients aged ≥12 years with metastatic Merkel-cell carcinoma, including those who have not received previous therapy
  • Approval considerations Accelerated approval, breakthrough therapy, fast track, priority review, orphan drug
  • Approval date March 23, 2017
  • See also III. New Indications listing
Besponsa (BLA)
Inotuzumab ozogamicin – Pfizer
  • Class/route First-in-class CD22-directed antibody-drug conjugate; intravenous injection
  • Indication For treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia
  • Approval considerations Breakthrough therapy, priority review, orphan drug
  • Approval date August 17, 2017
Bevyxxa (NME)
Betrixaban – Portola Pharmaceuticals
  • Class/route Factor Xa inhibitor; oral capsules
  • Indication For prophylaxis of VTE in adults hospitalized for an acute illness who are at risk for thromboembolic complications caused by moderate or severe restricted mobility and other risk factors for VTE
  • Approval considerations Fast track, priority review
  • Approval date June 23, 2017
Calquence (NME)
Acalabrutinib – AstraZeneca
  • Class/route Bruton’s tyrosine kinase inhibitor; oral capsules
  • Indication For treatment of adults with mantle-cell lymphoma who received ≥1 therapies
  • Approval considerations Accelerated approval, breakthrough therapy, priority review, orphan drug
  • Approval date October 31, 2017
Hemlibra (BLA)
Emicizumab-kxwh – Genentech
  • Class/route First-in-class bispecific factor IXa– and factor X–directed antibody; subcutaneous injection
  • Indication For routine prophylaxis to prevent or reduce bleeding episodes in adults and pediatric patients with hemophilia A and factor VIII inhibitors
  • Approval considerations Breakthrough therapy, priority review, orphan drug
  • Approval date November 16, 2017
Idhifa (NME)
Enasidenib – Celgene
  • Class/route First-in-class IDH2 inhibitor; oral tablets
  • Indication For treatment of adults with relapsed or refractory acute myeloid leukemia with IDH2 mutation, as detected by an FDA-approved test
  • Approval considerations Fast track, priority review, orphan drug
  • Approval date August 1, 2017
Imfinzi (BLA)
Durvalumab – AstraZeneca
  • Class/route PD-L1–blocking antibody; intravenous injection
  • Indication For treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy
  • Approval considerations Accelerated approval, breakthrough therapy, priority review
  • Approval date May 1, 2017
Kisqali (NME)
Ribociclib – Novartis
  • Class/route CDK4/CDK6 inhibitor; oral tablets
  • Indication For treatment, in combination with an aromatase inhibitor as initial endocrine-based therapy, of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer
  • Approval considerations Breakthrough therapy, priority review
  • Approval date March 13, 2017
Nerlynx (NME)
Neratinib – Puma
  • Class/route Kinase inhibitor; oral tablets
  • Indication For extended adjuvant treatment of adults with early-stage HER2-overexpressed/amplified breast cancer, after adjuvant trastuzumab-based therapy
  • Approval date July 17, 2017
Rydapt (NME)
Midostaurin – Novartis
  • Class/route First-in-class kinase inhibitor; oral capsules
  • Indication For treatment, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation, of adults with newly diagnosed acute myeloid leukemia and FLT3 mutation, as detected by an FDA-approved test
  • Approval considerations Breakthrough therapy, fast track, priority review, orphan drug
  • Approval date April 28, 2017
Symproic (NME)
Naldemedine – Purdue Pharma
  • Class/route Opioid antagonist; oral tablets
  • Indication For treatment of opioid-induced constipation in adults with chronic noncancer pain, including chronic pain related to previous cancer or its treatment in patients who do not require frequent opioid dosage escalation
  • Approval date March 23, 2017
Verzenio (NME)
Abemaciclib – Eli Lilly
  • Class/route CDK4/CDK6 inhibitor; oral tablets
  • Indications For treatment, in combination with fulvestrant, of women with HR-positive, HER2-negative advanced or metastatic breast cancer whose disease progressed after endocrine therapy; and as monotherapy for treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer whose disease progressed after endocrine therapy and chemotherapy in the metastatic setting
  • Approval considerations Breakthrough therapy, fast track, priority review
  • Approval date September 28, 2017
  • New IndicationFebruary 26, 2018 Read More
Xermelo (NME)
Telotristat ethyl – Lexicon
  • Class/route First-in-class tryptophan hydroxylase inhibitor; oral tablets
  • Indication For treatment of carcinoid syndrome diarrhea, in combination with SSA therapy, in adults whose condition is inadequately controlled by SSA therapy
  • Approval considerations Fast track, priority review, orphan drug
  • Approval date February 28, 2017
Zejula (NME)
Niraparib – Tesaro
  • Class/route Poly (ADP-ribose) polymerase inhibitor
  • Indication For maintenance treatment of adult women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy
  • Approval considerations Breakthrough therapy, fast track, priority review, orphan drug
  • Approval date March 27, 2017

ALK indicates anaplastic lymphoma kinase; BLA, biologic license application; CDK, cyclin-dependent kinase; FDA, US Food and Drug Administration; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; IDH2, isocitrate dehydrogenase-2; NME, new molecular entity; NSCLC, non–small-cell lung cancer; PD-L1, programmed-cell death ligand 1; SSA, somatostatin analog; VTE, venous thromboembolism.

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II. New Gene Therapies and Blood Products

Kymriah (new gene therapy)
Tisagenlecleucel – Novartis
  • Class/route First-in-class CD19-directed genetically modified autologous (CAR) T-cell immunotherapy; intravenous injection
  • Indication For treatment of young patients aged ≤25 years with B-cell precursor acute lymphoblastic leukemia that is refractory to other treatments or is in second or later relapse
  • Approval considerations Breakthrough therapy, priority review; REMS
  • Approval date August 30, 2017
Rebinyn (new blood product)
Coagulation factor IX recombinant, glycopegylated – Novo Nordisk
  • Class/route Recombinant DNA-derived coagulation factor IX concentrate; lyophilized powder for solution for intravenous injection
  • Indications For on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding, in adults and children with hemophilia B
  • Approval date May 31, 2017
Yescarta (new gene therapy)
Axicabtagene ciloleucel – Kite Pharma
  • Class/route CD19-directed genetically modified autologous (CAR) T-cell immunotherapy; intravenous injection
  • Indication For treatment of adults with relapsed or refractory large B-cell lymphoma after ≥2 lines of systemic therapies, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma
  • Approval considerations Breakthrough therapy, priority review, orphan drug; REMS
  • Approval date October 18, 2017

CAR indicates chimeric antigen receptor; DLBCL, diffuse large B-cell lymphoma; REMS, Risk Evaluation and Mitigation Strategy.

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III. New Indications, New Combinations, and New Biosimilars

Actemra (new indications)
Tocilizumab – Genentech
  • Class/route IL-6 receptor antagonist; intravenous or subcutaneous injection
  • New indications First drug for adults with giant-cell arteritis; first treatment for CAR T-cell–induced severe or life-threatening cytokine release syndrome in patients aged ≥2 years
  • Existing indications For treatment of adults with moderately to severely active rheumatoid arthritis; treatment of polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis in patients aged ≥2 years
  • Approval considerations Breakthrough therapy (giant­cell arteritis), orphan drug (CAR T-cell–induced cytokine release syndrome and giant-cell arteritis), priority review (giant-cell arteritis)
  • Approval dates May 22, 2017 (giant-cell arteritis); August 30, 2017 (cytokine release syndrome)
Alecensa (new indication)
Alectinib – Genentech
  • Class/route Tyrosine kinase inhibitor; oral capsules
  • New indication For first-line treatment of patients with ALK-positive metastatic NSCLC, as detected by an FDA-approved test
  • Existing indication For treatment of patients with ALK-positive metastatic NSCLC whose disease progressed during or who were intolerant of crizotinib therapy
  • Approval consideration Breakthrough therapy
  • Approval date November 6, 2017
Bavencio (new indication)
Avelumab – EMD Serono/Pfizer
  • Class/route PD-L1–blocking monoclonal antibody; intravenous injection
  • New indication For treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or after platinum-containing chemotherapy, or whose disease progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  • Existing indication Treatment of all patients aged ≥12 years with metastatic Merkel-cell carcinoma
  • Approval consideration Accelerated approval
  • Approval date May 9, 2017
  • See also I. NME and BLA listing
Blincyto (new indication)
Blinatumomab – Amgen
  • Class/route Bispecific CD19-directed CD3 T-cell engager; intravenous injection
  • New indication For treatment of Ph+ relapsed or refractory B-cell precursor acute lymphoblastic leukemia in adults and children
  • Existing indication For treatment of Ph– relapsed or refractory B-cell precursor acute lymphoblastic leukemia
  • Approval date July 11, 2017
Bosulif (new indication)
Bosutinib – Pfizer
  • Class/route Tyrosine kinase inhibitor (BCR-ABL inhibitor); oral tablets
  • New indication For treatment of newly diagnosed chronic-phase Ph+ chronic myelogenous leukemia
  • Existing indications For treatment of chronic-, accelerated-, or blast-phase Ph+ chronic myelogenous leukemia that is resistant to or intolerant of previous therapy
  • Approval considerations Accelerated approval, orphan drug, priority review
  • Approval date December 19, 2017
Cabometyx (new indication)
Cabozantinib – Exelixis
  • Class/route Tyrosine kinase inhibitor; oral tablets
  • New indication For first-line treatment of patients with advanced renal-cell carcinoma
  • Existing indication For treatment of patients with advanced renal-cell carcinoma who have received anti­angiogenic therapy
  • Approval consideration Priority review
  • Approval date December 19, 2017
Darzalex (new indication)
Daratumumab – Janssen Biotech
  • Class/route CD38-directed cytolytic antibody; intra­venous injection
  • New indication For treatment, in combination with pomalidomide and dexamethasone, of patients with multiple myeloma who have received ≥2 therapies, including lenalidomide and a proteasome inhibitor
  • Existing indications For treatment, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, of patients with multiple myeloma who have received ≥1 therapies; as monotherapy for treatment of patients with multiple myeloma who have received ≥3 lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or whose disease is double refractory to a proteasome inhibitor and an immunomodulatory agent
  • Approval date June 16, 2017
Gazyva (new indication)
Obinutuzumab – Genentech
  • Class/route CD20-directed cytolytic antibody; intra­venous injection
  • New indication For first-line treatment, in combination with chemotherapy, followed by obinutuzumab monotherapy in patients achieving at least partial remission, of patients with untreated stage II bulky, stage III, or stage IV follicular lymphoma in adults
  • Existing indications For treatment, in combination with chlorambucil, of untreated chronic lymphocytic leukemia; treatment, in combination with bendamustine followed by obinutuzumab monotherapy, of follicular lymphoma in patients whose disease relapsed after or is refractory to a rituximab-containing regimen
  • Approval consideration Priority review
  • Approval date November 16, 2017
Ibrance (new indication)
Palbociclib – Pfizer
  • Class/route CDK4/CKD6 inhibitor; oral capsules
  • New indication For treatment, in combination with an aromatase inhibitor as initial endocrine-based therapy, of postmenopausal women with HR-positive, HER2-­negative advanced or metastatic breast cancer
  • Existing indications For treatment, in combination with letrozole, of ER-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy in postmenopausal women; treatment, in combination with fulvestrant, of HR-positive, HER2-negative advanced or metastatic breast cancer in women whose disease progressed after endocrine therapy
  • Approval considerations Breakthrough therapy, priority review
  • Approval date March 31, 2017
Imbruvica (new indications)
Ibrutinib – Pharmacyclics
  • Class/route Bruton’s tyrosine kinase inhibitor; oral capsules/tablets
  • New indications First treatment for adults with chronic graft-versus-host disease (GVHD), after failure of ≥1 systemic therapies; first treatment for relapsed or refractory marginal-zone lymphoma (MZL) in patients requiring systemic therapy, ≥1 anti-CD20–based therapies
  • Existing indications For treatment of chronic lympho­cytic leukemia or small lymphocytic lymphoma, with or without 17p deletion; treatment of Waldenström’s macroglobulinemia; treatment of mantle-cell lymphoma
  • Approval considerations Accelerated approval (MZL), breakthrough therapy (GVHD, MZL), orphan drug (both), priority review (GVHD)
  • Approval dates January 19, 2017 (MZL); August 2, 2017 (GVHD)
  • New dose February 16, 2018: once-daily tablet Read More
Keytruda (new indications)
Pembrolizumab – Merck
  • Class/route PD-1–blocking antibody; intravenous injection
  • New indications For treatment of refractory classical Hodgkin lymphoma or disease that relapsed after ≥3 previous therapies; treatment, in combination with pemetrexed and carboplatin, of previously untreated metastatic nonsquamous NSCLC; treatment of locally advanced or metastatic urothelial carcinoma in patients who are not eligible for cisplatin-containing chemotherapy; treatment of locally advanced or metastatic urothelial carcinoma in patients whose disease progressed during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; first drug approved based on a biomarker for treatment of unresectable or metastatic MSI-H or dMMR solid tumor that progressed after previous treatment, and for MSI-H or dMMR colorectal cancer that progressed after treatment with fluoropyrimidine, oxaliplatin, and irinotecan; treatment of recurrent, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in patients whose tumors express PD-L1
  • Existing indications For treatment of unresectable or metastatic melanoma; for first-line monotherapy of metastatic NSCLC in patients whose tumors have high PD-L1 expression; treatment of recurrent or metastatic head and neck squamous-cell cancer in patients whose disease progressed during or after platinum-containing chemotherapy
  • Approval considerations Accelerated approval (NSCLC, first-line for urothelial carcinoma, solid tumors with MSI-H or dMMR biomarker); breakthrough therapy (second-line for urothelial carcinoma); priority review (NSCLC, urothelial carcinoma, solid tumors with MSI-H or dMMR biomarkers)
  • Approval dates March 15, 2017 (classical Hodgkin lymphoma); May 10, 2017 (NSCLC); May 18, 2017 (urothelial cancer); May 23, 2017 (solid tumor with MSI-H or dMMR biomarker); September 22, 2017 (gastric cancer)
Lynparza (new indication)
Olaparib – AstraZeneca
  • Class/route PARP inhibitor; oral tablets, oral capsules
  • New indication For maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who have had a complete or partial response to platinum-based chemotherapy
  • Existing indications For treatment of advanced ovarian cancer in patients with deleterious or suspected deleterious germline BRCA mutation who have received ≥3 lines of chemotherapy; treatment of advanced ovarian cancer in patients with deleterious or suspected deleterious germline BRCA mutation who have received ≥3 lines of chemotherapy
  • Approval consideration Fast track
  • Approval date August 17, 2017
  • [New indication January 12, 2018: For treatment of HER2-negative metastatic breast cancer in patients with deleterious or suspected deleterious germline BRCA mutation who have received chemotherapy]
  • See also IV. New Dosage Form listing
Mvasi (new biosimilar)
Bevacizumab-awwb – Amgen
  • Class/route VEGF-specific angiogenesis inhibitor; intravenous infusion
  • Reference drug Avastin (bevacizumab)
  • Indications For treatment of patients with metastatic colorectal cancer, in combination with intravenous 5-fluorouracil–based chemotherapy, or, in patients whose disease progressed with a bevacizumab-containing regimen, in combination with fluoropyrimidine­irinotecan– or fluoropyrimidine-oxaliplatin–based chemotherapy; unresectable, locally advanced, recurrent, or metastatic nonsquamous NSCLC, in combination with carboplatin and paclitaxel; treatment of glio­blastoma in adults whose disease progressed after a single-agent therapy; treatment of metastatic renal­cell carcinoma, in combination with interferon alfa; treatment of persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan
  • Approval date September 14, 2017
Mylotarg (new indications)
Gemtuzumab ozogamicin – Pfizer
  • New indications For treatment of newly diagnosed CD33-positive acute myeloid leukemia in adults; treatment of relapsed or refractory CD33-positive acute myeloid leukemia in pediatric patients aged ≥2 years
  • Existing indication Initially approved (in 2000) at a higher dose for treatment of adults with relapsed CD33-positive acute myeloid leukemia, this drug was withdrawn from the market (in 2010) by the manufacturer
  • Approval consideration Orphan drug
  • Approval date September 1, 2017
  • See also IV. New Dosage/Patient Population listings
Ogivri (new biosimilar)
Trastuzumab-dkst – Mylan
  • Class/route HER2/neu receptor antagonist
  • Reference drug Herceptin (trastuzumab)
  • Indications For adjuvant treatment of patients with HER2-overexpressing node-positive or node-negative breast cancer; treatment of patients with HER2-over­expressing metastatic breast cancer, in combination with paclitaxel or as a single agent; treatment of patients with HER2-overexpressing metastatic gastric or gastroeso­ph­ageal junction adenocarcinoma, in combination with cisplatin and capecitabine or 5-fluorouracil
  • Approval date December 1, 2017
Opdivo (new indications)
Nivolumab – Bristol-Myers Squibb
  • Class/route PD-1–blocking antibody; intravenous injection
  • New indications For adjuvant treatment of patients with melanoma with lymph node involvement or in patients with metastatic disease who had complete resection; treatment of hepatocellular carcinoma in patients who have previously received sorafenib; treatment of locally advanced or metastatic urothelial carcinoma; treatment of patients aged ≥12 years with MSI-H or dMMR metastatic colorectal cancer that progressed after treatment with fluoropyrimidine, oxaliplatin, and irinotecan
  • Existing indications For treatment, in combination with ipilimumab, of patients with BRAF V600 wild-type and BRAF V600 mutation–positive unresectable or metastatic melanoma; treatment of classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem-cell transplantation and posttransplant brentuximab vedotin; treatment of recurrent or metastatic squamous-cell carcinoma of the head and neck; treatment of metastatic NSCLC; treatment of renal-cell carcinoma
  • Approval considerations Accelerated approval (hepatocellular carcinoma, colorectal cancer); breakthrough therapy (melanoma, urothelial carcinoma); priority review (colorectal cancer, hepatocellular carcinoma, melanoma, urothelial carcinoma)
  • Approval dates February 2, 2017 (urothelial carcinoma); July 31, 2017 (colorectal cancer); September 22, 2017 (hepatocellular carcinoma); December 20, 2017 (melanoma)
Revlimid (new indication)
Lenalidomide – Celgene
  • Class/route Thalidomide analog; oral capsules
  • New indication First drug for maintenance therapy in patients with multiple myeloma after autologous stem-cell transplant
  • Existing indication For treatment, in combination with dexamethasone therapy, of multiple myeloma; for treatment of transfusion-dependent anemia that results from low- or intermediate-1–risk myelodysplastic syndromes associated with a deletion 5q abnormality, with or without additional cytogenetic abnormalities; treatment of mantle-cell lymphoma in patients whose disease has relapsed or progressed after 2 therapies, one of which included bortezomib
  • Approval consideration REMS
  • Approval date February 22, 2017
Rituxan Hycela (new combination)
Rituximab and hyaluronidase human – Genentech
  • Class/route CD20-directed cytolytic antibody and endoglycosidase; subcutaneous injection
  • Indications For treatment of adults with untreated relapsed or refractory follicular lymphoma; treatment of untreated diffuse large B-cell lymphoma, in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone, or with other anthracycline-based chemotherapy regimens; treatment, in combination with fludarabine and cyclophosphamide, of patients with untreated or treated chronic lymphocytic leukemia
  • Approval date June 22, 2017
Somatuline Depot (new indications)
Lanreotide – Ipsen
  • Class/route Somatostatin analog; subcutaneous injection
  • New indications For treatment of adults with carcinoid syndrome; to reduce the frequency of short-acting somatostatin analog rescue therapy
  • Existing indications For long-term treatment of patients with acromegaly who have had an inadequate response to or cannot have surgery and/or radiotherapy; treatment of adults with unresectable, well- or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors to improve progression-free survival
  • Approval date September 18, 2017
Stivarga (new indication)
Regorafenib – Bayer HealthCare
  • Class/route Tyrosine kinase inhibitor; oral tablets
  • New indication For treatment of hepatocellular carcinoma in patients who have received sorafenib
  • Existing indications For treatment of metastatic colorectal cancer in patients who have received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy; for treatment of locally advanced, unresectable or metastatic GIST in patients who have received imatinib mesylate and sunitinib malate therapy
  • Approval considerations Orphan drug, priority review
  • Approval date April 27, 2017
Sutent (new indication)
Sunitinib malate – Pfizer
  • Class/route Tyrosine kinase inhibitor; oral capsules
  • New indication For adjuvant treatment of adults at high risk for recurrent renal-cell carcinoma after nephrectomy
  • Existing indications Treatment of GIST in patients who are intolerant of or whose disease progressed after imatinib mesylate; treatment of advanced renal-cell carcinoma; treatment of progressive, well-differentiated unresectable locally advanced or metastatic pancreatic neuroendocrine tumors
  • Approval date November 16, 2017
Tafinlar and Mekinist (new indication)
Dabrafenib and trametinib – Novartis
  • Class/routes Kinase inhibitor of BRAF pathway: kinase inhibitor of MEK1 and MEK2 pathway; oral capsules and oral tablets
  • New indication For treatment of metastatic NSCLC with BRAF V600E mutation, as detected by an FDA-approved test
  • Existing indication For treatment of unresectable or metastatic melanoma in patients with BRAF V600E or V600K mutations, as detected by an FDA-approved test
  • Approval date June 22, 2017
Tasigna (new indication)
Nilotinib – Novartis
  • Class/route BCR-ABL kinase inhibitor; oral capsules
  • New indication First FDA approval for treatment discontinuation of a drug in patients with chronic-phase chronic myeloid leukemia who have been taking nilotinib for ≥3 years and whose disease has responded to treatment, as detected by an FDA-approved test
  • Existing indications Treatment (ongoing) of adults with newly diagnosed chronic-phase Ph+ chronic myeloid leukemia; treatment (ongoing) of chronic-phase and accelerated-phase Ph+ chronic myeloid leukemia in adults with disease that is resistant to or who are intolerant of previous therapy that included imatinib
  • Approval considerations Orphan drug, priority review
  • Approval date December 22, 2017
Tecentriq (new indication)
Atezolizumab – Genentech
  • Class/route PD-L1–blocking antibody; intravenous injection
  • New indication For first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy
  • Existing indications Treatment of locally advanced or metastatic urothelial carcinoma in patients whose disease progressed during or after a platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy; treatment of metastatic NSCLC in patients whose disease progressed during or after platinum-containing chemotherapy
  • Approval consideration Accelerated approval
  • Approval date April 17, 2017
Vyxeos (new combination)
Daunorubicin and cytarabine – Jazz Pharmaceuticals
  • Classes/route Anthracycline topoisomerase inhibitor and nucleoside metabolic inhibitor; intravenous injection
  • Indications For treatment of adults with newly diagnosed therapy-related acute myeloid leukemia; treatment of adults with newly diagnosed acute myeloid leukemia with myelodysplasia-related changes
  • Approval considerations Breakthrough therapy, orphan drug, priority review
  • Approval date August 3, 2017
Zelboraf (new indication)
Vemurafenib – Genentech
  • Class/route BRAF serine-threonine kinase inhibitor; oral tablets
  • New indication First treatment for patients with Erdheim-Chester Disease with BRAF V600 mutation
  • Existing indications Treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation, as detected by an FDA-approved test; treatment, in combination with cobimetinib, of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation
  • Approval considerations Breakthrough therapy, orphan drug, priority review
  • Approval date November 6, 2017
Zykadia (new indication)
Ceritinib – Novartis
  • Class/route Tyrosine kinase inhibitor; oral capsules
  • New indication For treatment of metastatic NSCLC with ALK mutation, as detected by an FDA-approved test
  • Existing indications For treatment of metastatic NSCLC with ALK mutation in patients whose disease has progressed with or who are intolerant to crizotinib
  • Approval consideration Priority review
  • Approval date May 26, 2017

ALK indicates anaplastic lymphoma kinase; CAR, chimeric antigen receptor; CDK, cyclin-dependent kinase; dMMR, mismatch repair–deficient biomarker; EGFR, epidermal growth factor receptor; ER, estrogen receptor; FDA, US Food and Drug Administration; GIST, gastrointestinal stromal tumor; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; IL, interleukin; MEK, mitogen-activated extracellular signal-regulated kinase; MSI-H, microsatellite instability-high; NSCLC, non–small-cell lung cancer; PARP, poly (ADP-ribose) polymerase; PD-1/PD-L1, programmed-cell death receptor 1/ligand 1; Ph–, Philadelphia chromosome–negative; Ph+, Philadelphia chromosome–positive; REMS, Risk Evaluation and Mitigation Strategy; VEGF, vascular endothelial growth factor.

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IV. New Dosages, Dosage Forms, Formulations, and Patient Populations

Arymo ER (new formulation)
Morphine sulfate extended release – Egalet
  • Class/route Opioid agonist; oral tablets
  • New formulation 15-mg, 30-mg, and 60-mg film-coated, extended-release tablets with an abuse-deterrent formulation
  • Indication For management of pain severe enough to require daily, around-the-clock, long-term opioid treatment in patients for whom alternative treatments are inadequate
  • Approval date April 24, 2017
Endari (new formulation)
L-glutamine oral powder – Emmaus Medical
  • Class/route Amino acid; oral powder
  • New formulation 5-g L-glutamine powder per paper-foil-plastic laminate packet
  • Indication To reduce acute complications of sickle-cell disease in adults and pediatric patients aged ≥5 years; first treatment for sickle-cell disease in children aged ≥5 years
  • Approval date July 7, 2017
Lynparza (new dosage form)
Olaparib – AstraZeneca
  • Class/route PARP inhibitor; oral tablets, oral capsules
  • New dosage form Oral tablets
  • Existing dosage form Oral capsules, which are being phased out and will only be available through the Lynparza Specialty Pharmacy Network
  • Indications For maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have had a complete or partial response to platinum-based chemotherapy; treatment of HER2-negative metastatic breast cancer with deleterious or suspected deleterious germline BRCA mutation in patients who have received chemotherapy
  • Approval date August 17, 2017
  • See also III. New Indications listing
Mylotarg (new dosage/new patient population)
Gemtuzumab ozogamicin – Pfizer
  • Class/route CD33-directed antibody-drug conjugate; intravenous injection
  • New dosage 4.5-mg injection in 1 vial; dosing regimen varies by the patient’s age
  • New patient population Pediatric patients aged ≥2 years with relapsed or refractory CD33-positive acute myeloid leukemia
  • Indications For treatment of adults with newly diagnosed CD33-positive acute myeloid leukemia, in combination with daunorubicin and cytarabine; treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients aged ≥2 years
  • Approval date September 1, 2017
  • Note Mylotarg initially received accelerated approval in 2000 at a higher dose, for adults; the manufacturer removed it voluntarily from the market in 2010 because of serious adverse reactions at the higher dose
Narcan (new dosage form)
Naloxone hydrochloride – Adapt Pharma
  • Class/route Opioid antagonist; intranasal spray
  • New dosage form 2-mg dose
  • Existing dosage form 4-mg dose
  • Indication Emergency treatment of known or suspected opioid overdose
  • Approval date January 24, 2017
RoxyBond (new formulation)
Oxycodone hydrochloride – Inspirion Delivery Sciences
  • Class/route Opioid agonist; oral tablets
  • New formulation First immediate-release opioid analgesic 5-mg, 15-mg, and 30-mg tablets with the SentryBond abuse-deterrent formulation
  • Existing formulation Immediate-release 5-mg, 15-mg, and 30-mg tablets without abuse-deterrent properties
  • Indication For management of pain severe enough to require an opioid analgesic in patients for whom alternative treatments are inadequate
  • Approval date April 26, 2017
Sublocade (new dosage form)
Buprenorphine extended-release – Indivior
  • Class/route Partial opioid agonist; oral tablets, oral sublingual film, subdermal implant, subcutaneous injection
  • New dosage form First once-monthly injectable buprenorphine drug for the treatment of moderate-to-­severe opioid use disorder in adults who have initiated treatment with a transmucosal buprenorphine-containing drug
  • Existing dosage forms Oral tablets, oral sublingual film, subdermal implant
  • Indication For treatment of moderate-to-severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing drug
  • Approval date November 30, 2017
Tepadina (new formulation)
Thiotepa – Amneal Biosciences
  • Class/route Alkylating drug; intravenous, intracavitary, or intravesical injections
  • New formulation 100-mg vial
  • Existing formulation 15-mg vial
  • Indications To reduce the risk for graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem)-cell transplantation for pediatric patients with class 3 beta-thalassemia; for treatment of adenocarcinoma of the breast or ovary; for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities; for treatment of superficial papillary carcinoma of the urinary bladder
  • Approval date April 27, 2017
Vantrela ER (new formulation)
Hydrocodone bitartrate – Teva
  • Class/route Opioid agonist; oral tablets
  • New formulation 15-mg, 30-mg, 45-mg, 60-mg, and 90-mg extended-release tablets with proprietary abuse- deterrent technology
  • Existing formulation 20-mg, 30-mg, 40-mg, 60-mg, 80-mg, 100-mg, and 120-mg film-coated tablets without abuse-deterrent properties
  • Indication For management of pain severe enough to require daily, around-the-clock, long-term opioid treatment in patients for whom alternative treatments are inadequate
  • Approval date January 18, 2017

HER2 indicates human epidermal growth factor receptor 2; PARP, poly (ADP-ribose) polymerase.

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Last modified: May 21, 2018