Afatinib Granted Priority Review for Uncommon EGFR Mutations in Lung Cancer

Boehringer Ingelheim announced that the supplemental new drug application (sNDA) for afatinib (Gilotrif) has been granted priority review by the FDA, according to a press release.

The application for afatinib is being reviewed as a first-line therapy for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have an epidermal growth factor receptor (EGFR) exon 21 (L861Q), G719X, or S768I substitution mutations, according to Boehringer.

The submission was based on positive findings from a meta-analysis of studies from the LUX-Lung clinical trial program. These clinical trials explored the efficacy of afatinib in patients whose tumors have these uncommon EGFR mutations.

Investigators evaluated objective response, disease control, duration of response, progression-free survival, and overall survival.

Uncommon EGRF mutations—including L861Q, G719X, or S7681—account for less than 10% of EGFR mutations in NSCLC and are linked to poor prognosis and survival, according to the release.

Afatinib was previously approved in the United States and the European Union as a first-line therapy for patients with NSCLC with EGFR exon 19 deletions or exon 21 mutations or for patients with squamous cell carcinoma of the lung whose disease progressed after platinum-based chemotherapy, according to the release.

The most common side effects include diarrhea, rash, mouth sores, nail inflammation, dry skin, acne, decreased appetite, nausea, vomiting, and itching. Boehringer also advises that afatinib can cause serious side effects, including diarrhea, skin reactions, lung or breathing problems, liver problems, eye problems, or heart problems.

“The acceptance of the sNDA filing with priority review recognizes our company’s ongoing commitment to further study Gilotrif in areas of high unmet medical need for patients with few treatment options,” said Martina Flammer, MD, vice president, Clinical Development & Medical Affairs Specialty Care, Boehringer Ingelheim Pharmaceuticals, Inc. “If approved for this additional indication, Gilotrif would offer the broadest first-line treatment option for patients with EGFR mutation-positive NSCLC.”