Gilotrif

Drug - Gilotrif™ (afatinib) [Boehringer Ingelheim Pharmaceuticals, Inc.]

July 2017

Therapeutic area - Metastatic non-small cell lung cancer (NSCLC)

Approval criteria

• Patient must be at least 18 years of age AND
• Patient has a diagnosis of metastatic non-small cell lung cancer (NSCLC) AND
• Tumors have epidermal growth factor receptor (EGFR) exon 19 deletions OR exon 21 (L858R) substitution mutations as detected by an FDA-approved test OR
• Patient must be at least 18 years of age AND
• Patient has a diagnosis of metastatic, squamous NSCLC progressing after platinum-based chemotherapy

Quantity limit

Quantity limit = 30 tablets per 30 days (all strengths)

Background information

GILOTRIF™ is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution 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. 

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411