The FDA approved several indications in the month of June, including venetoclax (Venclexta) in chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL), the combination of binimetinib (Mektovi) plus encorafenib (Braftovi) in melanoma, and bevacizumab (Avastin) in ovarian cancer. The FDA also accelerated approvals for pembrolizumab (Keytruda) in cervical cancer and in primary mediastinal large B-cell lymphoma, while also granting a priority review to glasdegib for acute myeloid leukemia.
Previous indications for the Orbis Paxman Hair Loss Cooling System and for the combination pembrolizumab (Keytruda) plus atezolizumab (Tecentriq) have now been expanded to include certain patients with ovarian cancer and urothelial carcinoma, respectively.
A new drug application (NDA) for talazoparib as a treatment for breast cancer was accepted, as well as a few supplemental new drug applications (sBLAs) including for carfilzomib (Kyprolis) for multiple myeloma as well as nivolumab (Opdivo) and ipilimumab (Yervoy) for non-small cell lung cancer (NSCLC).
Here’s a look back on the FDA happenings for the month of June 2018:
A new drug application (NDA) for talazoparib was granted priority review for the treatment of patients with germlineBRCAmutation-positive, HER2-negative locally advanced or metastatic breast cancer. Pfizer, the manufacturer of the PARP inhibitor, made the announcement on June 7.
On June 8, a standard approval was granted by the FDA for venetoclax (Venclexta) as a treatment for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL), with or without 17p depletion and after at least 1 prior line of therapy.
A supplemental new drug application (sNDA) for carfilzomib (Kyprolis) was approved by the FDA on June 11. The sNDA suggests carfilzomib has benefit as a treatment option for patients with relapsed/refractory multiple myeloma.
An accelerated approval was granted by the FDA on June 12 to pembrolizumab for the treatment of patients with advanced, PD-L1-positive cervical cancer whose disease progressed on or after chemotherapy. This acceleration was based on results from the phase II KEYNOTE-158 trial.
On June 13, the FDA expanded an indication for the Orbis Paxman Hair Loss Cooling System. The updated indication now includes the prevention of chemotherapy-related alopecia in patients with solid tumors. Previously, the indication only covered those patients with breast cancer.
An accelerated approval was granted on June 13 by the FDA for pembrolizumab as treatment for adults and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or patients who had relapsed after a minimum of 2 prior lines of therapy.
Bevacizumab (Avastin) was approved by the FDA for treatment in combination with carboplatin and paclitaxel, followed by monotherapy of bevacizumab for patients with advanced ovarian cancer who have had initial surgical resection. This approval was announced on June 13.
The FDA updated labels on June 20 for pembrolizumab (Keytruda) and atezolizumab (Tecentriq). The 2 agents are now approved for use as frontline treatment for platinum-ineligible patients with urothelial carcinoma.
On June 21, an sBLA was submitted and accepted by the FDA for the combination of nivolumab (Opdivo) and ipilimumab (Yervoy). The application suggests the combination can be used as a treatment for patients with advanced non-small cell lung cancer with tumor mutational burden ≥10 mutations per megabase.
A supplemental biologics license application (sBLA) was accepted by the FDA on June 25 for pembrolizumab as an adjuvant treatment for patients with resected, high-risk stage III melanoma. The agent proved to reduce risk of recurrence or death by 43% in the phase III EORTC 1325-MG/KEYNOTE-054 trial. The results were also published in the New England Journal of Medicine and presented at the 2018 AACR Annual Meeting.
The FDA granted a priority review on June 25, 2018, to an sNDA for the combination of ibrutinib and rituximab for treatment of patients with Waldenstrom macroglobulinemia in all settings. This decisions comes based off a reduction in the risk of disease progression or death of 80% compared to treatment with rituximab alone.
On June 27, the combination of binimetinib (Mektovi) plus encorafenib (Braftovi) was approved for patients with BRAF+ melanoma, based on the results from the COLUMBUS trial. This phase III study compared the combination to vemurafenib (Zelboraf) alone and encorafenib alone in a randomized 1:1:1 design.