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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