Boehringer Ingelheim said the supplemental New Drug Application for Gilotrif (afatinib) has been accepted for filing and granted Priority Review by FDA. The application for Gilotrif is currently under review for first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 21 (L861Q), G719X, or S768I substitution mutations as detected by an FDA-approved test.
Boehringer Ingelheim’s Gilotrif granted Priority Review
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