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Merck Gets Positive EU CHMP Opinion For Expanded Approval Of Keytruda

Merck & Co. Inc. (MRK) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted a positive opinion recommending approval of an expanded label for the company's anti-PD-1 therapy Keytruda.

The CHMP is recommending KEYTRUDA as monotherapy for the treatment of adult and pediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.

The company noted that the recommendation was based on results from the pivotal Phase 3 KEYNOTE-204 trial, in which Keytruda monotherapy showed a significant improvement in progression-free survival (PFS) compared with brentuximab vedotin (BV), a commonly used treatment.

Keytruda reduced the risk of disease progression or death by 35% and showed a median PFS of 13.2 months versus 8.3 months for patients treated with BV.

The recommendation was also based on supportive data from an updated analysis of the KEYNOTE-087 trial, which supported the European Commission's (EC) approval of KEYTRUDA for the treatment of adult patients with relapsed or refractory cHL who have failed ASCT and BV or who are transplant ineligible and have failed BV.

The CHMP's recommendation will now be reviewed by the EC for marketing authorization in the European Union, and a final decision is expected in the first quarter of 2021.

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