CHMP positive for extension of indication of Keytruda (pembrolizumab)to include the pre- and post-operative treatment of adults whose NSCLC can be removed by surgery and who are at high risk of recurrence. Merck Inc.,
On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Keytruda to include the pre- and post-operative treatment of adults whose non-small cell lung carcinoma can be removed by surgery and who are at high risk of recurrence.
The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme B.V.
Keytruda, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non?small cell lung carcinoma at high risk of recurrence in adults .
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