Loxo Oncology has begun a rolling FDA submission for larotrectinib. The move positions Loxo to wrap up the filing for the Bayer-partnered TRK inhibitor early next year.
Stamford, Connecticut-based Loxo is seeking approval of the drug in a genetic subset of patients with unresectable or metastatic solid tumors. The subset consists of people with NTRK-fusion proteins, genetic alterations associated with tumor growth.
Loxo is heading to the FDA armed with data showing larotrectinib triggers tumor responses in most patients with these genetics. The patients in Loxo’s clinical development program had various types of cancer. The common and critical thread was the presence of NTRK-fusion proteins.
Until recently, it looked like Loxo would go through the regulatory and commercial processes without enlisting the support of a large partner. That changed when Bayer, attracted by the clinical trial data generated by Loxo, arrived with a wheelbarrow load of cash. Loxo expects its haul from the deal to pass the $1 billion mark within a few years.
The size of the sums involved reflects the demand for late-phasing cancer drugs and Bayer’s belief that Loxo is onto a winner.
“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," Carsten Brunn, president of Bayer Pharmaceuticals in the Americas, said in a statement. “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.”