MHLW Approves KEYTRUDA for Lung and Urothelial Cancers

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved MSD’s immunotherapy drug KEYTRUDA (pembrolizumab) for new indications in the treatment of lung and urothelial cancers. The approvals specifically cover non-small cell lung carcinoma (NSCLC) and radically unresectable urothelial carcinoma.

For NSCLC, KEYTRUDA is approved to be used alongside chemotherapy as a neoadjuvant treatment. Following this initial combination, KEYTRUDA can continue as a standalone therapy for adjuvant treatment. This particular approval is based on the results from the Phase III KEYNOTE-671 clinical trial, which demonstrated the efficacy of the drug in such treatment protocols.

Moreover, KEYTRUDA has been approved for use in combination with Padcev (enfortumab vedotin-ejfv) as a first-line treatment for patients with radically unresectable urothelial carcinoma. This decision was informed by the results of the Phase III KEYNOTE-A39 (EV-302) clinical trial, a collaborative endeavor between MSD, Pfizer, and Astellas.

Additionally, KEYTRUDA monotherapy has received approval for patients with radically unresectable urothelial carcinoma who are ineligible for any platinum-containing chemotherapy. This indication is supported by findings from the Phase II KEYNOTE-052 trial. Pembrolizumab is a humanized monoclonal antibody designed to enhance the immune system’s ability to recognize and attack tumor cells. It functions by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which can target both cancerous and healthy cells.

Presently, there are over 1,600 clinical trials investigating KEYTRUDA across various cancer types and treatment settings. Dr. Marjorie Green, the global clinical development oncology head and senior vice-president at Merck Research Laboratories, emphasized the importance of these approvals. She highlighted the urgent need for new and effective treatment options for patients in Japan diagnosed with resectable non-small cell lung carcinoma and radically unresectable urothelial carcinoma. With these new approvals, MSD aims to provide KEYTRUDA both as a monotherapy and in combination with other treatments to meet the unmet medical needs of these patients.

This recent development follows the earlier approval by the US Food and Drug Administration (FDA) of the KEYTRUDA regimen as a first-line treatment for adults with unresectable advanced or metastatic malignant pleural mesothelioma. The continuous regulatory endorsements reflect the growing confidence in KEYTRUDA's versatility and efficacy across different cancer treatments.