Merck & Co. recently revealed its intention to introduce a subcutaneous version of Keytruda, its cancer immunotherapy, to the US market on October 1. The subcutaneous formulation of Keytruda is still awaiting approval from the U.S. Food and Drug Administration (FDA), with a decision expected by September 23.
Merck explained that administering Keytruda via subcutaneous injection, as opposed to intravenous infusion, could significantly reduce the time patients spend receiving treatment.
Merck’s Senior Vice President of Oncology stated in an interview that they plan to ship the product immediately following approval, ensuring sufficient supply to meet market demand within 1-2 weeks.
Keytruda, approved for treating various types of cancer, is currently the world’s best-selling prescription drug. Sales are projected to reach approximately $30 billion in 2024.
Industry experts predict that Merck, which has relied heavily on Keytruda for growth in recent years, could benefit from intellectual property protection for the subcutaneous version before Keytruda’s primary patent expires in 2028. Alteogen, a South Korean pharmaceutical company, is developing and manufacturing an enzyme used in the subcutaneous formulation of Keytruda.
