Merck (MRK) announced the CHMP of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA, the company's anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. The positive opinion is based on results from the pivotal phase 3 KEYNOTE-564 trial.
The CHMP's recommendation will now be reviewed by the European Commission, and a final decision is anticipated in the first quarter of 2022.
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