What's Happening?
Bristol Myers Squibb (BMS) is preparing to file for regulatory approval of its new multiple myeloma drug, iberdomide, following positive results from a phase 3 trial. The trial, known as EXCALIBER-RRMM, demonstrated that iberdomide, a cereblon E3 ligase modulator or 'celmod', achieved a statistically significant improvement in minimal residual disease (MRD) negativity when combined with other therapies. This development is crucial for BMS as it seeks to replace its current multiple myeloma blockbusters, Revlimid and Pomalyst, which are facing patent expirations. Revlimid, which generated $5.8 billion in sales last year, is already seeing a decline due to generic competition, while Pomalyst, with $3.5 billion in sales, will lose patent protection in the U.S. next year. Iberdomide is positioned as a successor to Revlimid, and the study will continue to assess additional clinical endpoints such as progression-free survival and overall survival.
Why It's Important?
The advancement of iberdomide is significant for BMS as it navigates the impending loss of market exclusivity for its key multiple myeloma drugs. The successful development and approval of iberdomide could help BMS maintain its leadership in the multiple myeloma market, which is crucial for its financial stability. The loss of exclusivity for Revlimid and Pomalyst could otherwise lead to a substantial revenue decline. Additionally, the development of iberdomide and other celmods like golcadomide and mezigdomide reflects BMS's strategic focus on targeted protein degradation, a promising area in oncology. The competition in this space is intensifying, with companies like C4 Therapeutics and Nurix also developing similar therapies, highlighting the importance of BMS's progress in maintaining a competitive edge.
What's Next?
BMS plans to discuss the trial results with regulatory authorities, although no specific timeline for marketing applications has been provided. The continuation of the EXCALIBER-RRMM study will further evaluate iberdomide's efficacy and safety, with completion expected next year. As BMS moves forward, it will need to navigate the competitive landscape, where other companies are developing similar therapies. The outcome of these regulatory discussions and subsequent approvals will be critical for BMS's strategy to offset the revenue impact from the loss of exclusivity of its current drugs.
