FDA accepts sNDA for Braftovi + Mektovi to treat metastatic non-small cell lung cancer with a BRAF V600E mutation
Pfizer Inc. announced that the FDA has accepted for review the Supplemental New Drug Applications (sNDAs) for Braftovi (encorafenib) + Mektovi (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in Fourth-Quarter 2023 for the sNDAs
In the U.S., Braftovi + Mektovi is currently approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.Braftovi is also approved, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
“For more than a decade, Pfizer Oncology has been at the forefront of bringing biomarker-driven treatment options to patients with cancer. Since their initial regulatory approvals, Braftovi and Mektovi have helped improve outcomes in their respective indications of BRAF-mutated metastatic melanoma and BRAF-mutated metastatic colorectal cancer," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. "Through our comprehensive development program, the Braftovi and Mektovi combination has shown the potential to help more patients, such as those living with BRAF V600E-mutant non-small cell lung cancer. These sNDAs build on Pfizer’s long heritage of meeting the diverse needs of people with NSCLC, and we look forward to working with the FDA on their review of these applications.”
These sNDAs are supported by results from the PHAROS trial (NCT03915951), an open-label, multicenter, non-randomized, Phase II study (n=98) to determine the safety, tolerability, and efficacy of Braftovi given in combination with Mektovi in patients with BRAF V600E-mutant metastatic NSCLC. PHAROS met its primary endpoint of objective response rate. Detailed results from the PHAROS study will be presented at an upcoming scientific congress.
About PHAROS:PHAROS (NCT03915951) is an open-label, multicenter, non-randomized, Phase II study to determine the safety, tolerability, and efficacy of Braftovi given in combination with Mektovi in 98 patients with BRAF V600E-mutant metastatic NSCLC. The primary endpoint is objective response rate, based on independent radiologic review (per RECIST v1.1); secondary objectives will evaluate additional efficacy endpoints and safety. Duration of response is a key secondary endpoint. The trial is conducted across 53 sites in: Italy (5 sites), the Netherlands (2 sites), South Korea (3 sites), Spain (4 sites), and the U.S. (39 sites)
Pfizer has exclusive rights to Braftovi and Mehktovi in the U.S., Canada, and all countries in the Latin America, Africa, and Middle East regions. Ono Pharmaceutical Co. Ltd. has exclusive rights to commercialize both products in Japan and South Korea, Medison has exclusive rights in Israel, and Pierre Fabre has exclusive rights in all other countries, including Europe and Asia-Pacific (excluding Japan and South Korea)
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.