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Loxo Oncology Drug gains FDA Breakthrough status

September 6, 2018

Loxo Oncology, which is developing cancer treatments, announced this week that it had gained Breakthrough Therapy Designation from the U.S. Food and Drug Administration for its Loxo-292 drug.

The Breakthrough classification aims to speed up the development and review of a drug intended to treat certain types of lung and thyroid cancers based on their genetic characteristics and that has already undergone extensive clinical testing.

“We look forward to working with FDA to streamline the development of Loxo-292 in the two patient populations that have comprised the bulk of our initial clinical trial enrollment,” Loxo CEO Josh Bilenker said in a statement. “Given the many available therapies for non-small-cell lung cancer and medullary thyroid cancer, we are pleased that Loxo-292 has shown encouraging data in ‘refractory’ patients and hope to demonstrate the full potential of this treatment in additional populations over time.”

Next year, the company plans to give an update on Loxo-292’s long-term clinical development plan, based on feedback from global regulators. Company officials did not say in their latest announcement when they expected Loxo-292 to go on the market.

Among other recent regulatory milestones, Loxo announced in December it had launched an application to the FDA for another drug, larotrectinib.

A month earlier, the company finalized a partnership with pharmaceutical giant Bayer that could be worth more than $1 billion to Loxo.

As part of the agreement, Loxo would receive a $400 million upfront payment. The firm would then be eligible to receive $450 million for regulatory approvals and first sales in certain markets related to larotrectinib and an additional $200 million linked to regulatory progress and initial sales of another drug under development, Loxo-195. Bayer would also pay Loxo double-digit percentage royalties on sales milestones totaling $500 million.

In June 2017, Loxo received about $261 million from a public offering. It is using the proceeds for commercialization activities related to larotrectinib; research-and-development initiatives for other drugs and additional uses that could include acquisitions or investments.

Clinical progress has galvanized investor support for Loxo. At the American Society of Clinical Oncology’s 2017 annual meeting, a doctor from Memorial Sloan Kettering Cancer announced larotrectinib significantly shrank tumors in 76 percent of patients participating in recent trials.

Founded in 2013, Loxo is based at 281 Tresser Blvd., in downtown Stamford. It takes its name from a term in Greek mythology referring to the trajectory of an arrow, a metaphor that company officials said describes their firm’s approach to developing cancer therapies.

pschott@scni.com; 203-964-2236; Twitter: @paulschott

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