Pembrolizumab plus Lenvatinib Combination Receives Regular Approval for Advanced Endometrial Carcinoma

August 2021 Vol 14, Special Issue: Payers' Perspectives in Oncology - FDA Approvals, Conference Highlights ASCO

On July 21, 2021, the FDA granted full approval for the PD-1 inhibitor pembrolizumab (Keytruda; Merck), in combination with the kinase inhibitor lenvatinib (Lenvima; Eisai), for the treatment of advanced endometrial carcinoma that is not MSI-H (microsatellite instability-high) or dMMR (mismatch repair-deficient), in patients whose disease progressed after previous systemic therapy in any setting, and who are not candidates for curative surgery or radiation. The FDA granted this combination a priority review and a breakthrough therapy designation for this indication. In September 2019, the FDA granted accelerated approval to the combination of pembrolizumab plus lenvatinib for this indication.

The current regular FDA approval of pembrolizumab plus lenvatinib for this indication was based on the confirmatory results of Study 309/KEYNOTE-775, a multicenter, open-label, randomized, active-controlled clinical trial conducted to confirm the clinical benefit of the previous accelerated approval.

Pembrolizumab and lenvatinib are each approved by the FDA for many indications, alone and in combination with other drugs.

Related Items
Opdivo plus Platinum-Based Chemotherapy FDA Approved as First Neoadjuvant Treatment in Early-Stage NSCLC
Web Exclusives published on May 26, 2022 in FDA Approvals
Lynparza Receives FDA Approval for Adjuvant Treatment of High-Risk Early Breast Cancer with BRCA Mutation
Web Exclusives published on May 19, 2022 in FDA Approvals
Keytruda Monotherapy FDA Approved for Endometrial Carcinoma with a Biomarker
Web Exclusives published on May 16, 2022 in FDA Approvals
Carvykti Second BCMA-Directed CAR T-Cell Therapy FDA Approved for Multiple Myeloma
Web Exclusives published on May 5, 2022 in FDA Approvals
Opdualag, a Novel Immunotherapy Combination, FDA Approved for Advanced Melanoma
Web Exclusives published on May 3, 2022 in FDA Approvals
Last modified: August 30, 2021
Copyright © Engage Healthcare Communications, LLC. All rights reserved.