Expanded Indication for Gilotrif
January 16, 2018 – The U.S. FDA has approved an expanded indication for Gilotrif® (afatinib), manufactured by Boehringer Ingelheim. A tyrosine kinase inhibitor, Gilotrif is now approved as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have non-resistant epidermal growth factor receptor (EGFR) L861Q, G719X, or S768I mutations. These mutations are identified by an FDA-approved diagnostic test.
According to the Levine Cancer Institute, the presence of these three EGFR mutations generally results in a poor prognosis and limited treatment options for patients. It is hoped that Gilotrif’s expanded indication will provide new approaches to treatment for patients with lung cancer who are affected by these mutations.
Gilotrif’s previous indications include use as a first-line treatment for NSCLC in patients whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as well as use as a treatment for squamous cell carcinoma of the lung in patients who experience disease progression following treatment with platinum-based chemotherapy. Recommended dosing is one 40mg tablet taken once per day at least one hour before or two hours after eating. For patients who have severe renal impairment, the dosage should be decreased to 30mg per day.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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-FDA-0178
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