Merck MRK has announced that the FDA has accepted a regulatory submission seeking approval for the subcutaneous (skin or SC) formulation of the hit drug keytruda (pembrolizumab).
This filing calls for an agency’s nod to the SC version across all solid tumor indications where the intravenous (venous or IV) version of the drug has already been approved.
A final decision is expected by September 23, 2025.
Regulatory submissions are supported by data from the key phase III 3475A-D77 study evaluated for IV versions (both versions) for first-line treatment of adult patients with metastatic non-small cell lung cancer (both versions). As published by Merck in November, the study achieved a major endpoint and demonstrated that treatment with the SC version of the drug is at least as effective as the IV version.
In addition to the above news, Merck also provided detailed results on the secondary endpoints of the 3475A-D77 study. Data from this study showed that patients treated with Keytruda SC achieved an objective response rate of 45.4% compared to 42.1% for the IV version. The results were comparable to the duration of response and progression-free survival endpoints. Overall survival results have not yet been reached for either weapon, but these results do not show a significant loss of efficacy in Keytruda SC.
Merck also published the results of the time and movement studies conducted along with the 3475A-D77 study. Data from this observational study showed that the formulation of SC reduced patient processing time by 49.7% and treatment room time by 47.4% compared to the IV version. Treatment with Keytruda SC reduced the aggressive treatment time of healthcare professionals by 45.7%, streamlined administration and increased efficiency.
Keytruda SC regulatory submissions are also under review by the European Union and are supported by the above results.
In line with the year, Merck’s stock lost nearly 11% against the industry’s 3% growth.
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Keytruda is the company’s leading revenue driver, accounting for nearly 46% of its revenue in 2024. Sales of this flagship cancer drug rose 18% to $29.5 billion due to the continued momentum in metastasis indications and the continued momentum of rapid intake in early stage launches. However, investors have expressed concern about the potential loss of the exclusiveness of the IV version since 2028. KeytrudaIV is currently approved for over 40 different indications.
