Gilotrif to debut in the USA in week starting Sept 2

The US subsidiary of family-owned German drug major Boehringer Ingelheim says that, following last month’s approval of Gilotrif (afatinib; The Pharma Letter July 1)), the drug will be commercially available in the USA the week of September 2.

The US Food and Drug Administration approved Gilotrif as a new first-line – or initial – treatment for patients with metastatic non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. Safety and efficacy of Gilotrif have not been established in patients whose tumors have other EGFR mutations, the company noted.

Supporting patient access program for Gilotrif