FDA Approves Eli Lilly Drug For Thyroid, Lung Cancers Driven By A Genetic Mutation

The U.S. Food and Drug Administration on Friday approved a drug to treat lung and thyroid cancers driven by a specific genetic mutation that Eli Lilly and Co acquired with its 2019 purchase of Loxo Oncology.The drug, selpercatinib, which works against cancers driven mutations of a gene known as RET, is part of a trend of treating cancer based on a patient's genetics rather than where in the body the disease originated. RET mutations occur in about 2% of lung cancers, 10% to 20% of papillary thyroid cancers.Lilly will price the drug to be sold under the brand name Retevmo at $20,600 for 30 days of treatment, said Anne White, head of Lilly's oncology division. The drug is designed to inhibit the mutated RET enzyme that drives cancer by triggering uncontrolled cancer cell growth. In clinical trials, it performed equally impressively regardless of where the cancer was located.The approval marks the first big potential payoff for Lilly's $8 billion bet on Loxo, a move Lilly hoped would bolster its presence in targeted cancer therapies and help offset patent losses of older big-selling drugs for diabetes and other conditions.Lilly, however, faces unique challenges in launching the drug during the raging coronavirus epidemic in the United States, which will curtail its ability to make in-person sales calls with much of the country just emerging from severe travel restrictions to limit the spread of the virus and other parts still under stay-at-home restrictions.Instead, Lilly plans to give oncologists access to educational materials about Retevmo and let sales representatives follow up with phone calls or video conference meetings, White said."It is very much launching in a different world from what we have done in the past," White added.Another U.S. drugmaker, Bristol Myers Squibb Co, delayed the launch of its recently-approved multiple sclerosis drug Zeposia (ozanimod) due to challenges of ramping up sales during the pandemic.Selpercatinib is the first drug from Loxo's pipeline that Lilly has brought to market. Prior to the acquisition, Loxo won approval of Vitrakvi, which targets a different genetic mutation and is sold by Bayer AG.Late last year, Lilly created a new cancer research division run by Loxo's former top executives dubbed Loxo Oncology at Lilly.The Indianapolis-based company has been focused on increasing sales in core franchises, including diabetes and oncology, as older blockbuster medicines such as diabetes treatment Humalog and erectile dysfunction drug Cialis face competition from cheaper generic versions. (Reporting by Carl O'Donnell Editing by Bill Berkrot)

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