The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2016 and are grouped into the following categories:
Axumin (NME) (Fluciclovine F 18; Blue Earth Diagnostics) Class/route: Radioactive diagnostic agent; intravenous injection Indication: For positron emission tomography imaging in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen levels after previous treatment Approval consideration: Priority review Approval date: May 27, 2016
Defitelio (NME) (Defibrotide; Jazz Pharmaceuticals) Class/route: First-in-class anticoagulant; intravenous infusion Indication: For the treatment of adults and pediatric patients with hepatic veno-occlusive disease with renal or pulmonary dysfunction after hematopoietic stem-cell transplantation Approval considerations: Fast track, priority review, orphan drug Approval date: March 30, 2016
Lartruvo (BLA) (Olaratumab; Eli Lilly) Class/route: Platelet-derived growth factor receptor- alpha–blocking antibody; intravenous injection Indication: For the treatment, in combination with doxorubicin, of adults with soft-tissue sarcoma and a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery Approval considerations: Accelerated approval, breakthrough therapy, fast track, priority review, orphan drug Approval date: October 19, 2016
Netspot (NME) (Kit for preparation of gallium Ga 68 dotatate injection; Gipharma) Class/route: Radioactive diagnostic agent; intravenous injection Indication: For use with positron emission tomography for the localization of somatostatin receptor–positive neuroendocrine tumors in adults and in pediatric patients Approval considerations: Priority review, orphan drug Approval date: June 1, 2016
Rubraca (NME) (Rucaparib; Clovis Oncology) Class/route: Poly ADP-ribose polymerase inhibitor; oral Indication: For the treatment of patients with deleterious BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer who received ≥2 chemotherapies; patients should be selected for therapy based on an FDA-approved companion diagnostic for rucaparib Approval considerations: Accelerated approval, breakthrough therapy, priority review, orphan drug Approval date: December 19, 2016
Tecentriq (BLA) (Atezolizumab; Genentech) Class/route: PD-L1; intravenous infusion Indications: For the treatment of patients with locally advanced or metastatic urothelial carcinoma with disease progression during or after platinum-containing chemotherapy, or with disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; and for the treatment of patients with metastatic non–small-cell lung cancer whose disease progressed during or after platinum-containing chemotherapy. Patients with EGFR or ALK mutations should have disease progression with FDA-approved therapy for these aberrations before using atezolizumab Approval considerations: Accelerated approval, breakthrough therapy, priority review Approval dates: May 18, 2016 (bladder cancer); October 18, 2016 (lung cancer) Venclexta (NME) (Venetoclax; AbbVie/Genentech) Class/route: First-in-class BCL-2 inhibitor; oral Indication: For the treatment of patients with chronic lymphocytic leukemia with 17p deletion (as detected by an FDA-approved test) who have received at least 1 previous therapy Approval considerations: Accelerated approval, breakthrough therapy, priority review, orphan drug Approval date: April 11, 2016
BLA indicates biologic license application; NME, new molecular entity; PD-L1, programmed-cell death ligand 1.
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Afinitor (new indication) (Everolimus; Novartis) Class/route: Serine-threonine kinase inhibitor; oral tablets New Indication: For treatment of adults with progressive neuroendocrine tumors of pancreatic origin and adults with progressive, well-differentiated, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin that are unresectable, locally advanced, or metastatic Existing Indications: For treatment of, in combination with exemestane after nonresponse to treatment with letrozole or anastrozole, postmenopausal women with advanced HR-positive, HER2-negative breast cancer; for adults with advanced renal-cell carcinoma after nonresponse to treatment with sunitinib or sorafenib; for adults with renal angiomyolipoma and tuberous sclerosis complex not requiring immediate surgery
Arzerra (new indications) (Ofatumumab; Novartis) Class/route: CD20-directed cytolytic monoclonal antibody; intravenous injection New Indications: For treatment of relapsed CLL in combination with fludarabine and cyclophosphamide; for extended treatment of recurrent or progressive CLL in patients with complete or partial response after at least 2 lines of therapy Existing Indications: For treatment of, in combination with chlorambucil, treatment-naïve patients with CLL for whom fludarabine-based therapy is inappropriate; for patients with CLL refractory to fludarabine and to alemtuzumab
Avastin (new indications) (Bevacizumab; Genentech) Class/route: VEGF inhibitor; intravenous infusion New Indications: For treatment, in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine chemotherapy, followed by bevacizumab alone, of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and for recurrent epithelial ovarian, fallopian, or primary peritoneal cancer that is platinum-sensitive, in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by bevacizumab as a single agent Existing Indications: For treatment, in combination with paclitaxel, with pegylated liposomal doxorubicin, or with topotecan, of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and in combination with chemotherapy, for treatment of patients with metastatic colorectal cancer; nonsquamous NSCLC; glioblastoma; metastatic renal-cell carcinoma; or cervical cancer Approval consideration: Priority review
Blincyto (new indication) (Blinatumomab; Amgen) Class/route: Bispecific CD19-directed CD3 T-cell engager; intravenous injection New Indication: For treatment of pediatric patients with Ph-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia Existing Indication: For treatment of adults with Ph- negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia Approval considerations: Accelerated approval, REMS program
Darzalex (new indication) (Daratumumab; Janssen Biotech) Class/route: CD38-directed cytolytic antibody; intravenous injection New Indication: For treatment, in combination with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, of patients with multiple myeloma who have received at least 1 previous therapy Existing Indications: For use as monotherapy in patients with multiple myeloma who have received at least 3 previous lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or those who are double refractory to a proteasome inhibitor and an immunomodulatory agent Approval consideration: Breakthrough therapy
Gazyva (new indication) (Obinutuzumab; Genentech) Class/route: CD20-directed cytolytic antibody; intravenous injection New Indication: For treatment of, in combination with bendamustine followed by obinutuzumab monotherapy, patients with follicular lymphoma whose disease relapsed after, or who are refractory to, a rituximabcontaining regimen Existing Indication: For treatment, in combination with chlorambucil, of patients with previously untreated CLL Approval consideration: Priority review Gilotrif (new indication) (Afatinib; Boehringer Ingelheim) Class/route: TKI; oral tablets New Indication: For treatment of patients with metastatic squamous NSCLC that has progressed after platinum-based chemotherapy Existing Indication: For first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test
Halaven (new indication) (Eribulin mesylate; Eisai) Class/route: Microtubule inhibitor; intravenous injection New Indication: For treatment of unresectable or metastatic liposarcoma in patients who have received an anthracycline-containing regimen Existing Indication: For treatment of metastatic breast cancer in patients who have received ≥2 chemotherapeutic regimens, including an anthracycline and a taxane in the adjuvant or metastatic setting Approval considerations: Orphan drug, priority review
Ibrance (new indication) (Palbociclib; Pfizer) Class/route: CDK4 and CDK6 inhibitor; oral capsules New Indication: For treatment, in combination with fulvestrant, of women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression after endocrine therapy Existing Indication: For treatment of, in combination with letrozole as initial endocrine-based therapy in postmenopausal women, with HR-positive, HER2- negative advanced or metastatic breast cancer Approval considerations: Accelerated approval, breakthrough therapy, priority review
Imbruvica (new indications) (Ibrutinib; Pharmacyclics, Janssen Biotech) Class/route: Bruton’s TKI; oral capsules New Indications: For treatment of patients with CLL or SLL; for treatment of CLL or SLL in patients with 17p deletion (January 19, 2017: first nonchemotherapy approved for relapsed or refractory marginal zone lymphoma in patients requiring systemic therapy who had received at least 1 anti-CD20–based therapy) Existing Indications: For treatment of mantle-cell lymphoma in patients who have received at least 1 previous therapy; for treatment of Waldenström’s macroglobulinemia Keytruda (new indications) (Pembrolizumab; Merck) Class/route: PD-1–blocking antibody; intravenous injection New Indications: For treatment of metastatic NSCLC in patients whose tumors have high PD-L1 expression, as determined by an FDA-approved test, and no EGFR or ALK mutations and no previous systemic chemotherapy treatment; for treatment of metastatic NSCLC in patients whose tumors express PD-L1, as determined by an FDA-approved test, and disease progression during or after platinum-containing chemotherapy; for treatment of recurrent or metastatic head and neck squamous-cell carcinoma in patients with disease progression during or after platinum-containing chemotherapy Existing Indications: Unresectable or metastatic melanoma Approval consideration: Accelerated approval
Kyprolis (new indication) (Carfilzomib; Amgen) Class/route: Proteasome inhibitor; intravenous injection New Indication: For treatment of, in combination with dexamethasone or with lenalidomide plus dexamethasone, patients with relapsed or refractory multiple myeloma who have received 1 to 3 lines of therapy Existing Indication: As monotherapy for treatment of relapsed or refractory multiple myeloma in patients who have received ≥1 lines of therapy
Lenvima (new indication) (Lenvatinib; Eisai) Class/route: Receptor TKI; oral capsules New Indication: For treatment, in combination with everolimus, of patients with advanced renal-cell carcinoma after 1 previous antiangiogenic therapy Existing Indication: For treatment, as monotherapy, of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer Approval considerations: Priority review, breakthrough therapy Opdivo (new indications) (Nivolumab; Bristol-Myers Squibb) Class/route: PD-1–blocking antibody; intravenous injection New Indications: For treatment, in combination with ipilimumab, of patients with BRAF V600 wild-type and BRAF V600 mutation–positive unresectable or metastatic melanoma; classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem-cell transplantation and posttransplant brentuximab vedotin; for treatment of recurrent or metastatic squamous-cell carcinoma of the head and neck, with disease progression during or after platinum-based therapy Existing Indications: For treatment of metastatic melanoma; metastatic NSCLC; renal-cell carcinoma Approval consideration: Accelerated approval See also New Dosage listing
Tarceva See New Patient Population listing
Tecentriq See NMEs and New BLAs listing
Troxyca ER (new combination) (Oxycodone hydrochloride and naltrexone hydrochloride; Pfizer) Classes/route: Opioid agonist and opioid antagonist; extended-release, abuse-deterrent oral capsules, CII Indication: For management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate Approval consideration: REMS program
Xalkori (new indication) (Crizotinib; Pfizer) Class/route: Receptor TKI; oral capsules New Indication: For treatment of metastatic NSCLC in patients with ROS1 mutation Existing Indication: For treatment of metastatic NSCLC in patients with ALK mutation, as detected by an FDA-approved test
ALK indicates anaplastic lymphoma kinase; BLA, biologic license application; CDK, cyclin-dependent kinase; CLL, chronic lymphocytic leukemia; EGFR, epidermal growth factor receptor; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; NME, new molecular entity; NSCLC, non–small-cell lung cancer; PD, programmed-cell death; PD-L1, PD ligand 1; Ph, Philadelphia chromosome; REMS, Risk Evaluation and Mitigation Strategy; SLL, small lymphocytic lymphoma; TKI, tyrosine kinase inhibitor; VEGF, vascular endothelial growth factor.
Ameluz (new dosage form) (A minolevulinic acid hydrochloride; Biofrontera AG) Class/route: Porphyrin precursor; topical gel New dosage form: 10% gel Existing dosage form: 20% solution for topical use Indication: For the lesion-directed and field-directed treatment, in combination with photodynamic therapy using BF-RhodoLED lamp, of mild-to-moderate actinic keratoses on the face and scalp
Cabometyx (new dosage form) (Cabozantinib; Exelixis) Class/route: Kinase inhibitor; oral tablets New dosage form: 20-mg, 40-mg, and 60-mg tablets Existing dosage form: Oral capsules Indication: For treatment of advanced renal-cell carcinoma in patients who received previous antiangiogenic therapy
Evomela (new formulation) (Melphalan; Spectrum Pharmaceuticals) Class/route: Bischloroethylamine alkylating agent; intravenous infusion New formulation: Melphalan that is free of propylene glycol, with Captisol technology to improve the solubility and stability of melphalan Existing formulation: Melphalan with propylene glycol as a cosolvent Indications: For high-dose conditioning treatment before hematopoietic progenitor-cell transplantation in patients with multiple myeloma; for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate
Opdivo (new dosage) (Nivolumab; Bristol-Myers Squibb) Class/route: PD-1–blocking antibody; intravenous New dosage: 240 mg intravenously every 2 weeks until disease progression or intolerable toxicity Existing dosage: Single-dose regimen of 3 mg/kg intravenously every 2 weeks Indications: For unresectable or metastatic melanoma; metastatic NSCLC; advanced renal-cell carcinoma; Hodgkin lymphoma See also New Indications listing
Sustol extended-release (new formulation) (Granisetron; Heron Therapeutics) Class/route: Serotonin-3 receptor antagonist; subcutaneous injection New formulation: Extended-release injection using a polymer-based drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days Indication: For use in adults, in combination with other antiemetics, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide combination chemotherapy regimens
Syndros (new dosage form) (Dronabinol; Insys Therapeutics) Class/route: Cannabinoid; oral solution New dosage form: 5-mg/mL oral solution Existing dosage form: 2.5-mg, 5-mg, 10-mg capsules Indications: For treatment of anorexia associated with weight loss in patients with AIDS; for treatment of chemotherapy-induced nausea and vomiting in patients with cancer who had not responded adequately to conventional antiemetic treatments
Tarceva (new patient population) (Erlotinib; OSI Pharmaceuticals) Class/route: TKI; oral tablets New patient population: Patients with metastatic NSCLC and EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test, that is progressing after at least 1 previous chemotherapy regimen Existing patient population: Patients with locally advanced, unresectable, or metastatic pancreatic cancer Indications: For treatment of metastatic NSCLC with EGFR exon 19 deletions or exon 21 substitution mutations; for first-line treatment, in combination with gemcitabine, of locally advanced, unresectable or metastatic pancreatic cancer Xtampza ER (new formulation) (Oxycodone; Collegium Pharmaceutical) Class/route: Opioid agonist; oral capsules New formulation: Abuse-deterrent, extended-release, twice-daily oral capsules Indication: For management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate Approval consideration: REMS program
EGFR indicates epidermal growth factor receptor; NSCLC, non–small-cell lung cancer; PD-1, programmed-cell death 1; REMS, Risk Evaluation and Mitigation Strategy; TKI, tyrosine kinase inhibitor.
Cuvitru (new blood product) (Immune globulin subcutaneous; Baxalta US) Class/route: Immune globulin subcutaneous (human); subcutaneous infusion Indication: As replacement therapy for primary humoral immunodeficiency in adult and pediatric patients aged ≥2 years Idelvion (new blood product) (Coagulation factor IX, albumin fusion protein; CSL Behring) Class/route: Recombinant blood coagulation factor IX; intravenous infusion Indications: For children and adults with hemophilia B (congenital factor IX deficiency) for on-demand control and prevention of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes
Kovaltry (new blood product) (Antihemophilic factor; Bayer HealthCare) Class/route: Recombinant antihemophilic factor VIII concentrate; intravenous infusion Indications: For children and adults with hemophilia A (congenital factor VIII deficiency) for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes
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