The European Commission (EC) has approved Merck’s KEYTRUDA regimen for treating adult patients with resectable non-small cell lung cancer (NSCLC) at increased recurrence risk.
This approval follows the Committee for Medicinal Products for Human Use positive recommendation in February this year.
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KEYTRUDA, indicated for usage in combination with platinum-containing chemotherapy, will serve as a neoadjuvant treatment and continue as monotherapy for adjuvant treatment.
The EC’s decision is based on the double-blind, randomised Phase III KEYNOTE-671 trial outcomes.
The trial enrolled 797 patients with event-free survival (EFS) and overall survival (OS) as the dual primary endpoints of the trial.
At a median follow-up of 29.8 months, results showed a 28% reduction in the mortality risk and a 41% decrease in the disease recurrence, progression, or mortality risk in patients treated with the KEYTRUDA-based regimen.
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By GlobalDataThe median OS for patients receiving KEYTRUDA was notably higher than for those on the chemotherapy-placebo regimen, with the former not yet reached versus 52.4 months for the latter.
With this approval, the KEYTRUDA regimen can be marketed for this indication across all 27 EU member states, as well as in Liechtenstein, Iceland, Norway, and Northern Ireland.
This marks the sixth NSCLC indication for KEYTRUDA in the EU, contributing to its 27 overall indications in the region.
Merck Research Laboratories global clinical development, oncology senior vice-president and head Marjorie Green said: “The approval of the first anti-PD-1/L1 therapy as part of a treatment regimen in Europe for the neoadjuvant followed by adjuvant treatment of resectable NSCLC based on positive overall survival results demonstrates our continued progress to advance treatments in earlier stages of lung cancer.
“We are eager to build on this momentum as we plan to seek additional approvals of this regimen around the world, and to work together with the cancer community to help drive earlier diagnoses of lung cancer, an urgent need.”
The US Food and Drug Administration (FDA) granted approval to Merck’s sotatercept-csrk, known by the brand name WINREVAIR, for pulmonary arterial hypertension (PAH).
