Merck's Keytruda Receives Landmark 30th EU Approval for Two New Indications in Gynecologic Cancers

Merck’s groundbreaking immunotherapy drug, Keytruda (pembrolizumab), has reached a significant milestone, securing its 30th approval from the European Commission with two new indications for treating gynecologic cancers. This latest approval expands Keytruda’s reach to include the treatment of patients with advanced endometrial carcinoma and those with cervical cancer, expanding options for patients with these hard-to-treat cancers.

In collaboration with chemotherapy, Keytruda is now approved for adults with persistent, recurrent, or metastatic cervical cancer where PD-L1 expression is present. The European Commission also approved Keytruda, when used in combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. These approvals mark a notable step forward in gynecologic oncology, providing essential new options for patients facing limited treatments and poor outcomes.

Impact and Efficacy in Gynecologic Cancer

Keytruda, a monoclonal antibody that boosts the immune system’s response to cancer cells, has demonstrated robust results in clinical trials for both cervical and endometrial cancers. Studies revealed that patients treated with Keytruda, in combination with either chemotherapy or lenvatinib, showed significant improvements in progression-free survival and overall response rates. These advances are critical in the treatment of gynecologic cancers, where current options remain limited.

Dr. Gregory Lubiniecki, Vice President, Global Clinical Development at Merck Research Laboratories, expressed optimism about Keytruda’s expanding role in cancer care: “These approvals in cervical and endometrial cancers mark important progress for patients with advanced cancers who face a poor prognosis and have historically had limited treatment options. We are excited to build on our ongoing commitment to addressing these significant unmet needs.”

A Legacy of Innovation in Immunotherapy

With its 30th European approval, Keytruda continues to set new benchmarks in oncology care. It is already approved in Europe for a wide range of cancers, including lung, melanoma, and head and neck cancers, among others. This milestone further solidifies Merck’s position as a leader in immuno-oncology and its commitment to expanding therapeutic options for complex and often underserved patient populations.

The latest approvals underscore Merck’s dedication to pioneering life-saving treatments, bringing new hope to patients throughout Europe. The company is committed to ensuring widespread access to Keytruda and supporting physicians and healthcare systems in deploying this innovative therapy.