(News Bulletin 247) – Pfizer today announced that the United States Food and Drug Administration (FDA) has agreed to review Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with BRAF V600E mutant metastatic non-small cell lung cancer.
In the United States, 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 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 biomarker-based treatment options for cancer patients. Since their first regulatory approval, 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, Chief Development Officer, Oncology and Rare Diseases, Development world of Pfizer products.
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