Gilotrif Approved for Lung Cancer Treatment
April 15, 2016 – Gilotrif® (afatinib) received FDA approval for the treatment of those with metastatic squamous non-small cell lung cancer (NSCLC). Manufactured by Boehringer Ingelheim, Gilotrif is for patients whose disease has progressed after treatment with platinum-based chemotherapy. Originally approved in July 2013, Gilotrif is a kinase inhibitor for patients with metastatic NSCLC and whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 substitution mutations. Supplied as 20mg, 30mg, and 40mg tablets, the recommended dose for each indication is 40mg once daily.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-332-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.