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# 2 Pfizer sNDA Submitted for Lung Cancer Drugs
- URL: https://www.fdaweb.com/2-pfizer-snda-submitted-for-lung-cancer-drugs/
- Published: 2023-04-04T12:00:00.000Z
- Updated: 2026-09-14T18:23:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154137

FDA has accepted for review two Pfizer Supplemental NDAs for Braftovi (encorafenib) and Mektovi (binimetinib) and their use in patients with metastatic non-small cell lung cancer with a BRAF V600E mutation, as detected by an FDA-approved test. The agency has set a user fee review action target date for the fourth quarter.

The drugs are currently approved for treating patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, according to the company. Braftovi is also approved, in combination with cetuximab, for treating adult patients with metastatic colorectal cancer with a BRAF V600E mutation after prior therapy.