FDA News

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

December 2017, Vol 7, No 12 - FDA News

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, HER2­negative 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 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 ]