Opdivo wins thumbs up from CHMP for two indications, in lung and kidney cancers

Bristol-Myers Squibb ($BMY) breakthrough immuno-oncology drug Opdivo has been racking up approvals left and right since it hit the market last year and today it received recommendations for not one but two additional indications in Europe, where it has two approvals already.

The EU's Committee for Medicinal Products for Human Use (CHMP) recommended Opdivo be approved to treat patients with previously treated metastatic non-squamous non-small cell lung cancer patients, regardless of PD-L1 expression, as well as for use on patients with previously treated advanced renal cell carcinoma.

Last year Opdivo was authorized in Europe first for treating advanced melanoma and then for treatment of the advanced stages of a squamous non-small cell lung cancer (NSCLC).

The European Commission generally accepts CHMP recommendations within 90 days but since the final OK is not yet in hand, Bristol-Myers Squibb was characteristically restrained in its reaction to the news which further advances a drug that EvaluatePharma says will reach sales of $8.4 billion by 2020.

Michael Giordano

"Today's two positive CHMP opinions are important achievements and mean we are closer to reaching this goal for those with advanced non-squamous non-small cell lung cancer and renal cell carcinoma," Dr. Michael Giordano, who leads the oncology development for BMS, said in a statement.

For lung cancer, CHMP's recommendation was based on the CheckMate -057 study in which Opdivo demonstrated superior overall survival in previously treated metastatic non-squamous NSCLC with 51% of patients still alive after 1 year, compared with 39% of those treated with the current standard. In renal cell carcinoma, the CHMP positive opinion was based on the CheckMate -025 study in which patients who previously had been treated showed extended overall survival with a median of 25 months for those treated with Opdivo compared to 19.6 months for those on everolimus.

The drug, first approved by the FDA in late 2014 to treat melanoma, has been on a rocket ride. It was a big revenue driver for BMS in 2015, generating just short of blockbuster sales, $972 million, in its first year on the market. And there is more to come. Last month the FDA approved Opdivo for treatment of melanoma, regardless of their BRAF status. It also approved in concert with Yervoy, its first melanoma immunotherapy, for appropriate patients, BRAF mutation or no.

So far, Opdivo has sprinted to the lead in the new area of immuno-oncology. It is a market that analysts think will eventually hit $40 billion as the drugs get approvals for first-line use in cancers. But they say other drugmakers like Merck ($MRK), with its Keytruda, and drug candidates from AstraZeneca ($AZN) and Roche ($RHHBY) are not out of the race if they can get approvals for first-line uses.

- here's the EMA announcement
- here's BMS release

Special Report: The top 20 drugs in 2020--worldwide sales - Opdivo