FDA / Drug Updates

Alecensa a New First-Line Treatment for NSCLC with ALK Mutation

December 2017, Vol 8, No 5 - FDA News & Updates, Online First

On November 6, 2017, the FDA approved alectinib (Alecensa; Genentech) for the treatment of patients with ALK mutation–positive, metastatic non–small-cell lung cancer (NSCLC), as detected by an FDA-approved test. On the same day, the FDA also converted alectinib’s initial accelerated approval to a full approval for the treatment of patients with metastatic NSCLC and ALK mutation whose disease progressed with or who were intolerant of crizotinib (Xalkori). [ Read More ]

Verzenio a New CDK4/CDK6 Inhibitor Approved for Metastatic Breast Cancer

December 2017, Vol 8, No 5 - FDA News & Updates, Online First

On September 28, 2017, the FDA approved abemaciclib (Verzenio; Eli Lilly), a cyclin-dependent kinase (CDK)4/CDK6 inhibitor, in combination with fulvestrant, for the treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer that progressed after endocrine therapy, and as monotherapy for HR-positive, HER2-­negative advanced or metastatic breast cancer that progressed after endocrine therapy and previous chemotherapy in the metastatic setting. [ Read More ]

Yescarta Second Gene Therapy Approved by FDA and First CAR T-Cell Therapy for Large B-Cell Lymphoma

December 2017, Vol 8, No 5 - FDA News & Updates, Online First

On October 18, 2017, the FDA approved axicabtagene ciloleucel (Yescarta; Kite Pharma), a CD19-directed genetically modified CAR T-cell immunotherapy, for the treatment, after ≥2 lines of systemic therapies, of adults with several types of relapsed or refractory large B-cell lymphoma, including (1) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, (2) primary mediastinal large B-cell lymphoma, (3) high-grade B-cell lymphoma, and (4) DLBCL arising from follicular lymphoma. [ Read More ]

FDA News – August 2017

August 2017, Vol 8, No 4 | Payers’ Perspectives In Oncology: ASCO 2017 Highlights - FDA News & Updates

  • Enasidenib, a New Targeted Therapy Approved for Relapsed or Refractory AML, Shows Complete Remission in Some Patients
  • Ibrutinib First Treatment Approved by the FDA for Chronic Graft-versus-Host Disease
  • Vyxeos First Treatment Approved Specifically for 2 Types of High-Risk AML
  • First CAR T-Cell Therapy Unanimously Recommended by FDA Advisory Committee for Treatment of B-Cell ALL in Children and Young Adults
[ Read More ]

FDA News – June 2017

June 2017, Vol 8, No 3 - FDA News & Updates

  • Keytruda First Cancer Drug Approved for Any Solid Tumor Based on a Biomarker Instead of Tumor Site
  • Imfinzi a New PD-L1 Approved for Bladder Cancer After Platinum-Based Chemotherapy
  • 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
  • Zejula a New Maintenance Treatment Option for Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
  • Bavencio, a PD-L1 Inhibitor, First Nonchemotherapy Drug Approved for Merkel-Cell Carcinoma
[ Read More ]

FDA News – April 2017

April 2017, Vol 8, No 2 - FDA News & Updates

  • 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
[ Read More ]