FDA Approvals, News & Updates

Gilotrif Receives New Indication as First-Line Treatment for Metastatic NSCLC with Nonresistant EGFR Mutations

March 2018, Vol 8, No 3 - FDA Approvals, News & Updates

On January 12, 2018, afatinib (Gilotrif; Boehringer Ingelheim) received FDA approval as first-line treatment for patients with metastatic non–small-cell lung cancer (NSCLC) associated with nonresistant EGFR mutations as identified via an FDA-approved test. Afatinib received orphan drug status for this indication, and was approved under the FDA priority review process. [ Read More ]

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

December 2017, Vol 7, No 12 - FDA Approvals, News & Updates

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 Approvals, News & Updates

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 Approvals, News & Updates

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 ]