Blog: Decoding the Research

FDA approves Gilotrif (afatanib) for lung cancer patients

Published: July 23rd, 2013

Adding to our arsenal of targeted therapies against lung cancer, the FDA has approved Gilotrif (afantanib) for patients whose lung cancers test positive for certain types of the EGFR biomarker.

Between 10-35% of patients with non-small cell lung cancers will have tumors driven by EGFR. EGFR is a normal gene that tells cells to divide and grow to replace old or injured cells in the body. In cancer cells, mutations can cause EGFR to be constantly active, telling cells to divide and grow uncontrollably. 

Afatanib is a next generation EGFR targeted drug, similar to the other approved tyrosine kinase inhibitor targeting EGFR, Tarceva (erlotinib), and is approved for patients with specific types of mutations to the EGFR gene (EGFR exon 19 deletions or exon 21 L858R substitution gene mutations). Both erlotinib and afatanib are most likely to be effective in patients whose tumors have the EGFR mutation, and are approved by the FDA in combination with companion diagnostics. These molecular tests ensure that patients receiving these drugs indeed have the EGFR biomarker in their tumors.

Research is driving the development of new, more effective, and personalized treatments for lung cancer patients. Uniting Against Lung Cancer is funding some of the key researchers involved in this story, including a grant in 2010 to Dr. Katerina Politi at Yale to study afatanib in combination with cetuximab (an EGFR-targeted antibody). UALC-researchers are also exploring how afatanib could be beneficial to additional patients - read out blog post from last year about Dr. Politi's results and new directions for afatanib here.

Based on current studies, EGFR-positive patients have shown a 70% response rate to treatment, lasting longer than chemotherapy responses and with less toxicity. Because of this good chance for improved responses to treatment, professional guidelines recommend that all patients with advanced-stage lung adenocarcinoma should receive molecular testing for EGFR to determine eligibility for targeted therapy, regardless of clinical history. Patients should also be tested for ALK, another biomarker with an approved targeted therapy (crizotinib).

But, developing the drugs is only part of the battle. Doctors and patients need to know about these new treatment options, and have tumors tested to determine if patients can take advantage of new breakthrough treatments. Learn more about personalized medicine and molecular testing here.