(Reuters) – The U.S. Food and Drug Administration on Friday approved Bristol Myers Squibb Co’s 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 https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-nivolumab-plus-ipilimumab-first-line-mnsclc-pd-l1-tumor-expression-1.
Non-small cell lung cancer (NSCLC) accounts for about 85% of lung cancer cases, making it a lucrative market for drugmakers, but one currently dominated by Keytruda.
Bristol has struggled in its attempts to make the Opdivo and Yervoy combination the “first-line” of treatment in the NSCLC market, and in January 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, which spurs the immune system to fight cancer, is one of Bristol’s top-selling drugs but has been overtaken by Keytruda as the industry’s immuno-oncology leader.
Opdivo brought in sales of $7.20 billion in 2019, while Keytruda sales came in at $11.08 billion.
(Reporting by Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila and Shailesh Kuber)
