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FDA Approves Gilotrif for Type of Late-Stage NSCLC with Companion Diagnostic

doi: 10.1097/01.COT.0000433551.22367.6d

The U.S. Food and Drug Administration has approved the use of Gilotrif (afatinib) to treat patients with metastatic non-small cell lung cancer whose tumors express specific types of epidermal growth factor receptor gene mutations. The drug is a tyrosine kinase inhibitor that blocks proteins that promote cancer cell growth, and is intended for patients whose tumors express the EGFR exon 19 deletions or exon 21 L858R substitution gene mutations.

Also approved was the therascreen EGFR RGQ PCR Kit, a companion diagnostic that helps determine if a patient's lung cancer cells express the EGFR gene mutations.

“The approvals further illustrate how a greater understanding of the underlying molecular pathways of a disease can lead to the development of targeted treatments,” Richard Pazdur, MD, Director of the FDA's Office of Hematology and Oncology Products, said in a news release. “Gilotrif is the second drug approved this year for patients with untreated metastatic NSCLC whose tumors have the EGFR exon 19 deletions or exon 21 L858R substitution mutations.”

The FDA approved Tarceva (erlotinib), concurrently with the companion diagnostic cobas EGFR Mutation Test, for first-line treatment of patients with NSCLC in May (OT, 6/10/13 issue). Gilotrif was approved under the FDA's priority review program, which provides an expedited review for drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared with marketed products.



Gilotrif's approval is based on a clinical study of 345 patients with metastatic NSCLC with EGFR mutations, randomly assigned to receive the drug or up to six cycles of pemetrexed and cisplatin. Progression-free survival was 4.2 months longer in patients receiving Gilotrif compared with those receiving the chemotherapy drugs. There was no statistically significant difference in overall survival.

The approval of the therascreen EGFR RGQ PCR Kit was based on data from the clinical study used to support Gilotrif's approval.

Common side effects of the drug include diarrhea, acne-like skin breakouts, dry skin, pruritus, inflammation of the mouth, paronychia, decreased appetite, weight loss, cystitis, nose bleed, runny nose, fever, eye inflammation, and hypokalemia. Serious side effects include diarrhea that can result in kidney failure and severe dehydration, severe rash, lung inflammation, and liver toxicity.

Gilotrif is marketed by Boehringer Ingelheim Pharmaceuticals, Inc., and the therascreen EGFR RGQ PCR Kit is manufactured by QIAGEN Manchester Ltd.

© 2013 by Lippincott Williams & Wilkins, Inc.
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