The FDA has approved a new subcutaneous formulation of Merck’s immunotherapy Keytruda, offering patients a faster and less invasive method of administration compared to the traditional intravenous (IV) infusion.
Keytruda, a PD-1 inhibitor widely used across multiple cancer types, has until now been available only as an IV injection administered over 30 minutes. The newly cleared under-the-skin option can be delivered in a matter of minutes, potentially easing treatment logistics for both patients and healthcare providers. The approval was based on clinical trial data demonstrating that subcutaneous delivery achieved comparable levels of drug exposure to the IV formulation, with a safety profile consistent with previous evidence.
The availability of a more convenient route of administration could expand access to immunotherapy, particularly in community and outpatient settings where infusion capacity may be limited. Cancer patients who must receive ongoing therapy may also benefit from reduced treatment times and fewer disruptions to daily routines.
The FDA’s decision reflects a broader trend toward developing alternative administration routes for biologic therapies, aiming to improve patient experience without compromising efficacy. Merck is expected to roll out the subcutaneous option alongside the existing IV formulation to provide greater flexibility in care.
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