NEW YORK – Pfizer said on Tuesday that the US Food and Drug Administration has accepted its supplemental new drug applications (sNDAs) seeking approval for Braftovi (encorafenib) and Mektovi (binimetinib) as a combination treatment for patients with BRAF V600E-mutated metastatic non-small cell lung cancer.
The company expects the FDA to make a decision on its application in the fourth quarter of this year. Pfizer submitted data from the Phase II PHAROS trial, which met its primary endpoint of objective response rate. Researchers will present full results from the trial at an upcoming scientific meeting.
The Braftovi-Mektovi combination was approved in the US in 2018 for unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. In 2020, Braftovi plus Eli Lilly's Erbitux (cetuximab) was approved for BRAF V600E-mutated metastatic colorectal patients.
Pfizer is also studying the Braftovi-Mektovi combination with Erasca's ERK1/2 inhibitor ERAS-007 in metastatic BRAF V600E-mutated colorectal cancer. The firms believe adding ERAS-007 may combat acquired resistance to Braftovi-Mektovi in colorectal cancer patients.