FDA Approved Indications for this Orphan Drug:

First-line treatment of patients with metastatic non-small cell lung cancer (NSCLS) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

FDA Marketing Approval issued as of:

Orphan Drug exclusivity ends on:
Company Making and Marketing this drug:
Boehringer Ingelheim Pharmaceuticals, Inc.

FDA Designation Date:

FDA Drug Designation:
Treatment of epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).