'Breakthrough' designation for Loxo Oncology's LOXO-101

US biotech firm Loxo Oncology (Nasdaq: LOXO) has been granted Breakthrough Therapy designation for its investigational drug candidate LOXO-101 by the Food and Drug Administration, with the news sending the company’s shares up 9.1% at $27.36 in mid-morning trading today.

LOXO-101 is a selective inhibitor of tropomyosin receptor kinase (TRK), and the designation is “for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments.”

“We’re pleased to have been granted Breakthrough Therapy designation for LOXO-101 and look forward to working more closely with the FDA to bring this therapy to patients with TRK fusion cancers,” said Josh Bilenker, chief executive at Loxo Oncology. “Data presented to date from the ongoing adult and pediatric studies of LOXO-101 have demonstrated durable anti-tumor activity across TRK fusion cancers, further validating LOXO-101’s potential to address the unmet medical need among patients with these genetically defined cancers. We remain on track to provide an enrollment update regarding the LOXO-101 Phase II trial in the second half of 2016,” Dr Bilenker explained.