Boehringer Ingelheim’s Gilotrif is up against some stiff competition in the EGFR lung cancer space. But this week, it snagged a label update that will widen its reach.
Tuesday, the FDA approved the drug to treat first-line, non-small cell lung cancer patients bearing the L861Q, G719X and S768I EGFR mutations. Previously, Gilotrif had boasted the agency’s green light in first-line patients with EGFR exon 19 deletions or exon 21 L858R mutations, and with the new nod, the drug “offers the broadest first-line indication” in EGFR mutation-positive NSCLC of any in its class of tyrosine kinase inhibitors, BI said.
Compared with other EGFR mutations, the three newest to the Gilotrif label “are associated with a poor prognosis and limited treatment options,” Edward Kim, M.D., of the Levine Cancer Institute of Carolinas HealthCare System, said in a statement, adding that “the approval of Gilotrif as a targeted therapy for these additional non-resistant EGFR mutations significantly alters the treatment strategy for this population.”
Boehringer is hoping the green light can give it a boost against a pair of competitors also operating in the first-line EGFR lung cancer arena. In 2015, AstraZeneca’s Iressa roared back to life with a first-line nod, and at that point Gilotrif was already battling Tarceva from cancer behemoth Roche.
Plus, there's a new rival on its way in. After showing it could slash the risk of disease progression or death by 54% when pitted against Iressa and Tarceva, AstraZeneca's Tagrisso in December picked up the FDA's priority review tag, which will help it speed to the first-line EGFR market.
Meanwhile, other Gilotrif expansion efforts haven’t quite gone the way Boehringer would have liked. In 2016, the German pharma scrapped a pair of phase 3 trials studying the therapy in patients with locally advanced head and neck cancer who showed no signs of disease after chemo. The reason? An independent data monitoring committee “made the assessment that it would be highly unlikely” that Gilotrif could significantly top placebo.