Home Fairfield Stamford’s Loxo Oncology receives FDA approval on cancer drug

Stamford’s Loxo Oncology receives FDA approval on cancer drug

Loxo Oncology has announced that it received approval from the U.S. Food and Drug Administration (FDA) for its cancer drug Vitrakvi, also known as larotrectinib.

Loxo stamfordAccording to the Stamford-headquartered company, Vitrakvi is the first oral tropomyosin receptor kinase (TRK) inhibitor that can be used in the treatment of patients with cancers that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The FDA previously granted Vitrakvi breakthrough therapy designation, rare pediatric disease designation and orphan drug designation, and the new approval enables Loxo Oncology and its development partner Bayer to sell the drug in oral capsules and as a liquid formulation for adults and children.

“We are grateful to the investigators, research teams and patients who contributed to and participated in the larotrectinib clinical trials that supported this approval,” said Josh Bilenker, CEO of Loxo Oncology. “The approval of Vitrakvi is a testament to the relentless prioritization of biology in the drug development process. It is now even more critical to screen patients of all ages with advanced solid tumors for actionable genomic insights that could benefit their care or aid in their referral to clinical trials.”

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Phil Hall's writing for Westfair Communications has earned multiple awards from the Connecticut Press Club and the Connecticut Society of Professional Journalists. He is a former United Nations-based reporter for Fairchild Broadcast News and the author of 10 books (including the 2020 release "Moby Dick: The Radio Play" and the upcoming "Jesus Christ Movie Star," both published by BearManor Media). He is also the host of the SoundCloud podcast "The Online Movie Show," co-host of the WAPJ-FM talk show "Nutmeg Chatter" and a writer with credits in The New York Times, New York Daily News, Hartford Courant, Wired, The Hill's Congress Blog, Profit Confidential, The MReport and StockNews.com. Outside of journalism, he is also a horror movie actor - usually playing the creepy villain who gets badly killed at the end of each film.

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