FDA News & Updates

  • Darzalex Combined with Pomalidomide and Dexamethasone Approved for Relapsed/Refractory Multiple Myeloma
  • Rituximab Combination Now Approved in 3 Blood Cancers
  • First FDA-Approved Test to Help Detect Several Leukemias and Lymphomas
  • DigniCap Cooling System Receives Expanded Indication for Use in Patients with Solid Tumors
  • Blincyto Receives Expanded Indication to Include Patients with Ph+ B-Cell Precursor ALL
  • First CAR T-Cell Therapy Unanimously Recommended by FDA Advisory Committee for Treatment of B-Cell ALL in Children and Young Adults
  • Neratinib First Extended Adjuvant Treatment for Patients with Early-Stage, HER2-Positive Breast Cancer
  • Alunbrig, an Oral Kinase Inhibitor, Receives FDA Approval for NSCLC with ALK Mutation
  • Rydapt First Drug in Decades Approved by the FDA for Acute Myeloid Leukemia
  • Stivarga First Drug in a Decade Approved by the FDA for Liver Cancer
  • Atezolizumab Approved as First-Line Treatment for Advanced Bladder Cancer in Some Patients
  • Tagrisso Receives Full Approval for NSCLC with EGFR T790M Mutation
  • Bavencio, a PD-L1 Inhibitor, First Nonchemotherapy Drug Approved for Merkel-Cell Carcinoma
Following a year in which approximately 2 dozen cancer drugs were approved by the FDA, approvals in 2016 decreased by approximately 50% compared with 2015.
  • Keytruda Receives Accelerated Approval for Relapsed/Refractory Classical Hodgkin Lymphoma
  • Kisqali, a New CDK4/CDK6 Inhibitor, Approved for First-Line Therapy in HR-Positive, HER2-Negative Advanced Breast Cancer
  • Xermelo First Oral Treatment Approved for Carcinoid Syndrome Diarrhea in Patients with NETs
  • Revlimid Receives New Indication for Maintenance Therapy in Multiple Myeloma After Autologous Stem-Cell Transplant
  • Opdivo a New Option for Advanced or Metastatic Bladder Cancer
  • Imbruvica First Nonchemotherapy Drug Approved for Relapsed/Refractory Marginal Zone Lymphoma
  • Rubraca Receives Accelerated Approval for Advanced Ovarian Cancer
  • Zejula a New Option for Maintenance Treatment of Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
  • Keytruda Receives Accelerated Approval for Relapsed/Refractory Classical Hodgkin Lymphoma
  • Kisqali, a New CDK4/CDK6 Inhibitor, Approved as First-Line Therapy for HR-Positive, HER2-Negative Advanced Breast Cancer
  • Xermelo First Oral Treatment Approved for Carcinoid Syndrome Diarrhea in Patients with NETs
  • Revlimid Approved as Maintenance Therapy for Multiple Myeloma After Autologous Stem-Cell Transplantation
  • Opdivo Now Approved for Advanced or Metastatic Bladder Cancer
  • Imbruvica First Nonchemotherapy Drug Approved for Relapsed/Refractory Marginal Zone Lymphoma
  • Rubraca a New Treatment Option for Patients with Advanced Ovarian Cancer
On December 19, 2016, the FDA granted accelerated approval to rucaparib (Rubraca; Clovis Oncology Inc), a poly ADP-ribose polymerase inhibitor, for the treatment of patients with advanced ovarian cancer whose tumors have deleterious BRCA gene mutation, and who have been treated with ≥2 chemotherapies.
  • Rubraca Approved for Advanced Ovarian Cancer with BRCA Mutations
  • Avastin Approved for Platinum-Sensitive Ovarian Cancer
  • Darzalex Approved for Use in Combination with Standard Regimen for Multiple Myeloma
  • Opdivo Now Approved for Head and Neck Squamous-Cell Carcinoma
The FDA has granted accelerated approval of rucaparib (Rubraca), a poly ADP-ribose polymerase inhibitor, for the treatment of patients with advanced ovarian cancer whose tumors have deleterious BRCA gene mutation and have been treated with ≥2 chemotherapies. The administration also approved a companion diagnostic to the drug, FoundationFocus CDxBRCA, which is the first next-generation sequencing diagnostic test.
The FDA has granted approval to daratumumab (Darzalex) for the treatment of patients with multiple myeloma who have received ≥1 previous therapies, in combination with dexamethasone and either lenalidomide or bortezomib.
On August 10, 2016, the FDA approved granisetron extended-release (Sustol; Heron Therapeutics) injection, the first extended-release 5-hydroxytryptamine (5-HT3) receptor antagonist, in combination with other antiemetic drugs in adults.
Page 1 of 11
Results 1 - 10 of 108