Loxo Oncology has initiated a rolling Food and Drug Administration (FDA) submission for the approval of larotrectinib. This puts the biotech on course to finalize the filing for the Bayer-partnered TRK inhibitor by early next year.
Connecticut-based Loxo is going after approval for the drug in a genetic subdivision of patients with unresectable or metastatic solid tumors. The subdivision is made up of patients with NTRK-fusion proteins, which are genetic alterations that are correlated with tumor growth.
Loxo is going to present the FDA with solid data that reveals that the drug generates tumor responses in most patients that possess NTRK-fusion proteins. The patients in the biotech’s clinical development program all had assorted forms of cancer with the common and critical thread of the presence of the genetic alteration, NTRK-fusion proteins.
Not long ago, it seemed as the biotech sector would endure the regulatory as well as the commercial processes without soliciting the support of a partner. But then, Bayer was drawn in by the clinical trial data that Loxo had produced and came into a deal ready to sign some large checks. Loxo anticipates that its deal with the Big Pharma to surpass $1 billion within only a few years. The sizable deal shows the high demand within the industry for late-phasing cancer drugs as well as Bayer’s confidence that Loxo has a star candidate in its pipeline.
“Research has generated great interest in TRK as a potential target for cancer treatment because while TRK fusions occur rarely, they present broadly in various rare adult and pediatric tumors,” said Carsten Brunn, president of Bayer Pharmaceuticals in the Americas. “We are pleased with the initiation of the rolling NDA submission for larotrectinib which brings us one step closer to potentially providing a treatment option for these patients.”