Merck’s Keytruda receives positive response from European Medicines Agency

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Merck, on Monday, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as a neoadjuvant treatment and then as a monotherapy as adjuvant treatment after surgery for adults with locally advanced or early-stage triple-negative breast cancer.

Triple-negative breast cancer is an aggressive type of breast cancer, which has the highest risk of recurrence within the first five years after diagnosis and is associated with worse outcomes compared to other forms of breast cancer.

“This positive CHMP opinion reinforces our efforts to advance the treatment of breast cancer in Europe and expand the use of KEYTRUDA in TNBC to potentially help even more patients with this aggressive disease who are in need of new treatment options. We look forward to the European Commission’s decision and are excited about the prospect of bringing the first immunotherapy regimen for high-risk, early-stage TNBC to appropriate patients in Europe.”

Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories

The European Commission will now review the CHMP’s recommendation for European Union marketing authorization, with a final decision expected in the second quarter of 2022. If approved, this will be KEYTRUDA’s second indication in Europe for TNBC. KEYTRUDA with chemotherapy received FDA approval in October 2021 for the first-line treatment of patients with locally recurrent unresectable or metastatic TNBC.

Merck said that it is rapidly advancing a broad portfolio in gynecologic and breast cancers with an extensive clinical development program for KEYTRUDA and several other investigational and approved medicines across these areas.

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