FDA approves Bristol Myers combo therapy for lung cancer

(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.

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.