FDA approves Bristol-Myers combo therapy for lung cancer

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[May 16, 2020]  By Manas Mishra

(Reuters) - The U.S. Food and Drug Administration on Friday approved Bristol Myers Squibb Co's combination therapy for previously untreated patients with a form of lung cancer, a much-needed boost as the company battles the dominance of Merck's Keytruda.

The combination of Bristol's treatments, Opdivo and Yervoy, is approved for treating patients with non-small cell lung cancer, the FDA said.

Based on a median of nine doses of Opdivo and three of Yervoy, the estimated cost of the therapy is $104,233, a company spokeswoman told Reuters. The cost varies based on factors including indication and treatment duration.

Non-small cell lung cancer (NSCLC) accounts for about 85% of lung cancer cases, making it a lucrative market, which is currently dominated by Keytruda.



Opdivo, which spurs the immune system to fight cancer, is one of Bristol's top-selling drugs, but it has been overtaken by Keytruda as the industry's immuno-oncology leader.

Bristol had previously struggled in its attempts to make the Opdivo and Yervoy combination the "first-line" of treatment in the NSCLC market.

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In January, it withdrew the application for getting the treatment approved in Europe after regulators there balked at changes to the design of its clinical trials.

The company also suffered a blow last year when it reported that Opdivo in combination with chemotherapy failed to extend overall survival more than chemotherapy alone in advanced NSCLC.

Opdivo brought in sales of $7.20 billion in 2019, while Keytruda sales came in at $11.08 billion.

Yervoy's label carries a boxed warning, FDA's harshest, flagging risks of immune-mediated adverse reactions.

(Reporting by Manas Mishra and Manojna Maddipatla in Bengaluru; Editing by Shailesh Kuber and Arun Koyyur)

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