A Look Back at FDA News in the Month of November

A round-up of all the FDA activity that occurred in the month of November, including several approvals for hematologic malignancies.

GSK2857916 Receives FDA's Breakthrough Therapy Designation for Multiple Myeloma

On November 2, the B-cell maturation antigen (BCMA) antibody-drug conjugate GSK2857916 was granted a breakthrough therapy designation by the FDA for the treatment of patients with relapsed/refractory multiple myeloma, GlaxoSmithKline (GSK) announced.

Brentuximab Vedotin Submitted for FDA Approval as Treatment for Hodgkin Lymphoma

Brentuximab vedotin (Adcetris) was submitted for FDA approval in combination with Adriamycin, vinblastine, dacarbazine (AVD) for the frontline treatment of patients with advanced classical Hodgkin lymphoma. On November 2, Seattle Genetics, the company developing brentuximab vedotin, announced the submission of a supplemental new drug application for the CD30-targeted antibody-drug conjugate.

Vemurafenib Granted FDA Approval for Rare Blood Cancer

Based on findings from the phase II VE-BASKET study, vemurafenib (Zelboraf) was granted approval by the FDA on November 6 as a treatment for patients with BRAFV600-mutated Erdheim-Chester disease (ECD). This is the first approved therapy for this rare blood disorder.

Alectinib Approved by FDA for Frontline Treatment of ALK-Positive NSCLC

Alectinib (Alecensa) received FDA approval on November 6 for the frontline treatment of patients with ALK-positive metastatic non—small cell lung cancer (NSCLC), Genentech (Roche), the manufacturer of the second-generation ALK inhibitor, announced.

Fulvestrant/Abemaciclib Combo Receives FDA Approval for HR+/HER2- Breast Cancer

Based on phase III results from the MONARCH 2 trial, fulvestrant (Faslodex) was approved by the FDA on November 15 for use in combination with the CDK4/6 inhibitor abemaciclib (Verzenio) as a treatment for patients with HR+/HER2- advanced or metastatic breast cancer who have progressed after endocrine therapy.

Frontline Obinutuzumab Receives FDA Approval for Follicular Lymphoma

Obinutuzumab (Gazyva) was approved by the FDA in combination with chemotherapy, followed by obinutuzumab alone on November 16, for the first-line treatment of patients with advanced follicular lymphoma with stage II bulky, III or IV disease, according to Genentech, the manufacturer of the therapy.

IMPACT Tumor Profiling Assay Receives FDA Approval

On November 15, the FDA approved the IMPACT tumor profiling assay, while also making it easier for some device manufacturers to bring their products to market.

Adjuvant Sunitinib Granted FDA Approval for High-Risk RCC

On November 16, sunitinib (Sutent) was granted FDA approval for the adjuvant treatment of patients with renal cell carcinoma (RCC) who have received nephrectomy and are high risk for recurrence.

BCMA CAR T-Cell Therapy Granted FDA Approval in Myeloma

The anti—B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy bb2121 was granted a breakthrough therapy designation by the FDA on November 16 for previously treated patients with relapsed/refractory multiple myeloma.

Mogamulizumab Receives FDA's Priority Review for CTCL

On November 28, a biologics license application (BLA) for mogamulizumab was granted a priority review by the FDA for the treatment of patients with cutaneous T-cell lymphoma (CTCL) who have received at least 1 prior systemic therapy, Kyowa Hakko Kirin, the manufacturer of the anti-CCR4 monoclonal antibody, announced.

FoundationOne CDx Granted FDA Approval, CMS Agrees to Provide Coverage