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Loxo Oncology Gets Breakthrough Therapy Status From FDA For LOXO-101


Loxo Oncology, Inc. (NASDAQ: LOXO) revealed that the Food and Drug Administration has granted Breakthrough Therapy Designation to its LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK). It was "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."

Following the news, the stock traded more than 8 percent higher to $27.25 on Wednesday.

Loxo Oncology said the FDA's Breakthrough Therapy Status was planed expedite the development, as well as review a drug candidate, which is intended for use to treat a serious or life-threatening disease or condition. That was when preliminary clinical evidence indicated that the drug might illustrate considerable enhancement in the current treatments on one or more clinically significant endpoints.

The company's CEO, Josh Bilenker, said, "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."

He added, "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 2 trial in the second half of 2016."

The company indicated its LOXO-101 Breakthrough Therapy Status application included data from the ongoing first stage dose-escalation trial of LOXO-101 in adult patients with advanced solid tumors and the ongoing Phase 1 pediatric trial of LOXO-101 in patients with advanced solid tumors.

Posted-In: Biotech News FDA General


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