FDA News

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

December 2017, Vol 7, No 12 - FDA News

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 ]

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

December 2017, Vol 7, No 12 - FDA News

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 ]

Besponsa a New Treatment Option for Patients with Relapsed/Refractory B-Cell ALL

October 2017, Vol 7, No 10 - FDA News, Leukemia

On August 17, 2017, the FDA approved inotuzumab ozogamicin (Besponsa; Pfi­zer), a targeted therapy, for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). The drug blocks cancer growth by binding to B-cell ALL cells that express CD22. The FDA designated inotuzumab ozogamicin as an orphan drug and applied its priority review for this approval. [ Read More ]

FDA News – September 2017

September 2017, Vol 7, No 9 - FDA News

  • Enasidenib, a New Targeted Therapy Approved for Relapsed or Refractory AML
  • 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 Acute Lymphoblastic Leukemia in Young Patients
[ Read More ]

FDA News – August 2017

August 2017, Vol 7, No 8 - FDA News

  • 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
[ Read More ]

FDA News – June 2017

June 2017, Vol 7, No 6 - FDA News

  • 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
[ Read More ]

Zejula a New Maintenance Treatment Option for Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

May 2017, Vol 7, No 5 - FDA News

On March 27, 2017, the FDA accelerated the approval of niraparib (Zejula; Tesaro), a PARP inhibitor, for maintenance treatment of 3 types of cancers—recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer—in adults who had a complete or partial response to platinum-based chemotherapy. [ Read More ]

FDA News – April 2017

April 2017, Vol 7, No 4 - FDA News

  • 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
[ Read More ]