What's Happening?
MSD, known as Merck & Co in the US, has received FDA approval for the subcutaneous formulation of Keytruda, marking the first SC PD-1 blocker to be approved. The drug, marketed as Keytruda QLEX, offers faster administration and more flexibility for patients with 38 different solid tumor indications. MSD plans to expand its use to hematological indications, with ongoing trials exploring its potential in B-cell lymphomas. Despite the approval, analysts remain skeptical about its impact due to the looming patent cliff and competition from combination therapies.
Why It's Important?
Keytruda is a top-selling cancer drug, and the approval of its subcutaneous version could help MSD maintain its market position as the drug faces patent expiration in 2028. The SC format offers convenience for patients, potentially increasing its adoption in monotherapy settings. However, the drug's market edge may be challenged by combination therapies requiring intravenous administration, which could limit its impact on MSD's overall sales.
What's Next?
MSD forecasts that 30% to 40% of patients will switch to the subcutaneous version within two years. The company is conducting trials to expand its use in hematological cancers and assess patient preference. Analysts predict that while the SC format may boost sales initially, the impact of biosimilars and patent expiration will eventually affect MSD's profits.
