Bristol Myers Squibb Celebrates Dual Victories: FDA Approval and Legal Win

Bristol Myers Squibb (BMS) has secured two significant wins, bolstering its position in the oncology market and defending its intellectual property. The pharmaceutical giant received FDA approval for a new combination therapy in colorectal cancer and emerged victorious in a court battle over its multiple myeloma drug.

FDA Approves Opdivo-Yervoy Combination for Colorectal Cancer

The U.S. Food and Drug Administration (FDA) has granted approval for the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment for patients with unresectable or metastatic colorectal cancer (CRC). This approval specifically targets patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) genetic profiles.

The FDA's decision was based on data from the CheckMate-8HW study, which demonstrated significant benefits of the combination therapy:

• 38% reduction in the risk of disease progression or death compared to Opdivo monotherapy
• 79% improvement in progression-free survival (PFS) versus chemotherapy
• Rapid separation from Opdivo monotherapy in PFS, observed as early as two months into treatment
• Significantly higher overall response rate compared to Opdivo alone

Wendy Short Bartie, Senior Vice President of Oncology Commercialization at BMS, hailed the approval as a "milestone," stating that it opens up "an important new approach in the first-line setting" for patients with MSI-H/dMRR CRC, who continue to "face high unmet need."

This latest indication brings the total number of Opdivo's approved indications in the gastrointestinal space to nine, further solidifying BMS's position in oncology.

Legal Victory Upholds Pomalyst Patent

In a separate development, BMS secured a significant legal win when a Manhattan judge dismissed a proposed class action lawsuit alleging that the company had illegally maintained a monopoly on its multiple myeloma drug, Pomalyst.

U.S. District Judge Edgardo Ramos found that the plaintiffs, led by Blue Cross Blue Shield of Louisiana, failed to provide sufficient evidence to support their claims that BMS:

1. Committed fraud in securing certain patents for Pomalyst
2. Filed baseless lawsuits against generic drug developers through its subsidiary Celgene

This ruling protects BMS's intellectual property rights for Pomalyst, an oral thalidomide analog approved in 2013 for treating multiple myeloma patients who have undergone at least two prior lines of therapies. Despite being on the market for over a decade, Pomalyst continues to show strong performance, with worldwide sales increasing by 3% year-on-year to reach $3.5 billion in 2024.

Future Developments

BMS continues to expand its oncology portfolio, with an ongoing focus on the Opdivo-Yervoy combination. The company has submitted a supplemental Biologics License Application (sBLA) proposing the regimen for first-line treatment of unresectable hepatocellular carcinoma. The FDA's decision on this application is expected by April 21, potentially opening up another significant market for the combination therapy.