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(RTTNews) - Biopharma major Bristol-Myers Squibb Company (BMY) said Friday that it received a positive opinion from the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA for the use of Opdivo with Yervoy as first-line treatment for adult patients with unresectable or advanced hepatocellular carcinoma or HCC.

This recommendation is based on the results of the Phase 3 CheckMate -9DW clinical trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival or OS with the combination therapy.

The CHMP opinion will now be reviewed by the European Commission or EC, which has the authority to approve medicines in the European Union or EU. If approved, this combination therapy could provide a new first-line treatment option for patients with advanced liver cancer, a condition often associated with poor prognosis.

In the CheckMate -9DW trial, the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) showed a median OS of 23.7 months compared to 20.6 months for the investigator's choice of lenvatinib or sorafenib, demonstrating a significant improvement in survival.

Bristol Myers Squibb also highlighted that the safety profile of the combination therapy remained consistent with previous reports, with no new safety signals identified.

The company is optimistic about expanding the treatment landscape for HCC in the EU and is awaiting the European Commission's decision. This follows the FDA's acceptance of the company's supplemental Biologics License Application or sBLA in the U.S., with a goal date of April 21, 2025.

Bristol Myers Squibb continues to innovate in the immuno-oncology space, aiming to transform the treatment of cancer and expand options for patients with unmet needs.

BMY closed Thursday's (Jan.30 2025) trading at $59.14 up by 0.15%. In premarket trading Friday the stock is up 0.07% at $59.18.

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