A look back at all the FDA news that occurred 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.
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.
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 nonsmall cell lung cancer, according to Genentech (Roche), the manufacturer of the second-generation ALK inhibitor.
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.
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 (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.
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.
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.
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.
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).
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.
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.
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.
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.