The U.S. Food and Drug Administration is giving priority review to Boehringer Ingelheim’s request that the agency consider approving Gilotriftm (afatinib) for an additional category of lung cancer patients.
Gilotriftm is already approved for certain kinds of non-small cell lung cancer(NSCLC) patients. Boehringer Ingelheim filed a supplemental New Drug Application requesting that the agency approve it for patients with a rare type of NSCLC associated with poor survival. The priority review means the FDA will make a decision on the application at least four months earlier than normal.
Afatinib is marketed in the United States as Gilotriftm. Its brand name in the European Union, Mexico and Taiwan is Gilotrif.
Boehringer Ingelheim’s supplemental drug application asks that the FDA approve Gilotriftm for NSCLC patients with rare mutations in their epidermal growth factor receptor (EGFR) genes. The three mutations are L861Q, G719X and S768I.
The FDA’s decision to do a priority review of the application “recognizes our company’s ongoing commitment to further study Gilotrif in areas of high unmet medical need for patients with few treatment options,” Dr. Martina Flammer, Boehringer Ingelheim’s vice president of Clinical Development & Medical Affairs Specialty Care, said in a press release. “If approved for this additional indication, Gilotrif would offer the broadest first-line treatment option for patients with EGFR mutation-positive NSCLC.”
Gilotriftm is approved in the United States, Europe and other countries as a first-line therapy for NSCLC patients carrying a specific EGFR mutation signature — either exon 19 deletions or exon 21 (L858R) mutations. An exon is an area of a gene that contains coding to produce a protein.
Regulators have also approved Gilotriftm for patients with squamous cell lung cancer who have failed to respond to platinum-based chemotherapy.
An analysis that covered the combined results of three studies in Boehringer’s LUX-Lung clinical trial program set the stage for the drug application. The analysis dealt with Gilotriftm’s effectiveness in cancer patients with rare EGFR mutations, including L861Q, G719X and S7681. These genetic errors occur in less than 10 percent of EGFR mutations in NSCLC patients, but are linked to poor disease outcome and patient survival.
The FDA grants priority review to therapies with the potential to do a significantly better job than available therapies at diagnosing, preventing or treating serious conditions — or that appear to be safer. The agency decides on a supplemental application within six months of its submission. A standard review takes about 10 months.