A Look Back at FDA News in the Month of August

Acalabrutinib Granted Priority Review in MCL

On August 2, a new drug application for acalabrutinib was granted a priority review by the FDA for patients with previously-treated mantle cell lymphoma.

CPX-351 Approved by FDA for 2 Types of AML

On August 3, CPX-351 (Vyxeos), a fixed-combination of daunorubicin and cytarabine, was approved by the FDA for adult patients with newly diagnosed therapy-related acute myeloid leukemia or AML with myelodysplasia-related changes, based on an improvement in overall survival in a phase III study.

Frontline Alectinib Receives FDA's Priority Review for ALK-Positive NSCLC

A supplemental new drug application for alectinib (Alecensa) was granted a priority review by the FDA on August 3 for the frontline treatment of patients with ALK-positive locally advanced or metastatic non—small cell lung cancer, according to Genentech (Roche), the manufacturer of the second-generation ALK inhibitor.

Cabozantinib Submitted for FDA Approval in Frontline RCC

Exelixis submitted a supplemental New Drug Application to the FDA on August 15 for the multikinase inhibitor cabozantinib (Cabometyx) as treatment for previously untreated patients with advanced renal cell carcinoma.

Brentuximab Vedotin Granted Priority Review by FDA for CTCL

On August 15, a supplemental biologics license application for brentuximab vedotin (Adcetris) was granted a priority review by the FDA for the treatment of patients with cutaneous T-cell lymphoma.

Inotuzumab Ozogamicin Receives FDA Approval for ALL

Inotuzumab ozogamicin (Besponsa) received FDA approval on August 16 for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, based on findings from the phase III INO-VATE trial. The approval comes with a boxed warning for hepatotoxicity and warning of an increased risk of death following certain types of stem cell transplant.

Olaparib Tablets Approved by FDA for Ovarian Cancer Treatment

On August 16, the FDA granted its approval to olaparib tablets (Lynparza) as a maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status.

Frontline Fulvestrant Receives FDA Approval for HR-Positive/HER2-Negative Breast Cancer

Fulvestrant (Faslodex) was approved by the FDA on August 27 for use in hormone receptor HR-positive, HER2-negative locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.

Frontline Obinutuzumab Receives FDA's Priority Review for Follicular Lymphoma

A supplemental biologics license application for obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone, was granted a priority review by the FDA on August 27 for the first-line treatment of patients with follicular lymphoma.

DS-8201 Receives FDA's Breakthrough Therapy Designation for HER2+ Breast Cancer

On August 29, the FDA granted breakthrough therapy designation to the investigational HER2-targeting antibody-drug conjugate DS-8201 for the treatment of patients with HER2-positive, locally advanced, or metastatic breast cancer who have been treated with trastuzumab (Herceptin) and pertuzumab (Perjeta) and have disease progression after ado-trastuzumab emtansine (T-DM1; Kadcyla).

Frontline Bosutinib Receives FDA's Priority Review for CML

A supplemental new drug application for bosutinib (Bosulif) was granted a priority review by the FDA on August 29 for the first-line treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia. The agency is scheduled to make a final decision by December 2017.

FDA Gives OK to First CAR T-Cell Therapy as Tisagenlecleucel Approved for ALL

On August 30, a historic approval of the first chimeric antigen receptor (CAR) T-cell therapy was issued by the FDA, authorizing the use of tisagenlecleucel (Kymriah) for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse.

FDA Extends Decision Deadline on Trastuzumab Biosimilar MYL-1401O

On August 30, the decision deadline on a biologics license application for MYL-1401O, a trastuzumab (Herceptin) biosimilar co-developed by Mylan and Biocon, was extended by 3 months, the FDA has announced. Under the new timeframe, a final decision is expected on or before December 3, 2017.

FDA Releases Data on Two Halted Pembrolizumab Trials in Myeloma

On August 31, the FDA released a statement providing specific data from 2 phase III trials placed on hold in July investigating pembrolizumab (Keytruda) in multiple myeloma.

sNDA for Carfilzomib Label Update in Myeloma Accepted by FDA