EU Approves Merck’s Keytruda For Lung Cancer Chemotherapy

(CTN News) – The European Commission approved Merck’s Keytruda anti-PD-1 therapy as a neoadjuvant treatment and monotherapy afterwards for patients with resectable non-small cell lung cancer in combination with platinum-containing chemotherapy.

It has already been shown to be effective in treating half a dozen types of non-small cell lung cancer (NSCLC). Adults with resectable NSCLC who are at high risk of recurrence are eligible for the new expansion.

Merck states that this approval marks the first European approval of an anti-PD-1/L1 therapy for resectable NSCLC based on positive overall survival results, and the sixth approval for Keytruda in lung cancer.

Due to the positive results of the Phase III KEYNOTE-671 trial, the European regulator has approved the application. Following just under 30 months of treatment, the regimen significantly improved overall survival, reducing the risk of death by 28%, regardless of PD-L1 status.

In addition to improving event-free survival rates, patients treated showed a 41% reduction in risk of disease recurrence, progression, or death.

Although lung cancer has been greatly improved over the past few decades, it still accounts for around one in five cancer deaths in the United States, despite advancements.

With this announcement, Keytruda has now been approved by the European Commission for a sixth indication for lung cancer, making it 27 indications in total. In October 2023, the U.S. approved the same use, specifying tumor sizes greater than or equal to four centimeters and nodes positive.

Merck has been granted approval to market the Keytruda regimen in all 27 EU member states as well as Iceland, Liechtenstein, Norway, and Northern Ireland as a result of Thursday’s decision.

During the year 2023, Merck generated $25 billion in sales from Keytruda. Sales of the cancer drug are expected to reach $30 billion by 2026. As a result, Keytruda is likely to face a patent cliff at the end of the decade.

To mitigate the effects of the patent expiration, Merck is developing combined immunotherapy approaches to supercharge its targeted therapies as well as continuing to study Keytruda in order to expand it further.

Merck Research Laboratories’ head of oncology, Marjorie Green, commented that they are eager to seize the momentum as they pursue the approval of their regimen around the world.

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