Sign Up Now!
To sign up for our newsletter or print publications, please enter your contact information below.
First Name *
Last Name *
Email Address (Verify) *
We will request your mailing address on the next page.
We will request your mailing address on the next page.

FULL APPROVALS

Pembrolizumab plus Lenvatinib Combination Receives Regular Approval for Advanced Endometrial Carcinoma

Web Exclusives - FDA Updates

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
Tivdak First Antibody–Drug Conjugate FDA Approved for Recurrent or Metastatic Cervical Cancer
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Exkivity Novel Oral Targeted Therapy Approved for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Welireg FDA Approved for 3 Tumor Types Associated with von Hippel-Lindau Disease
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Rezurock Novel Oral Therapy FDA Approved for Chronic Graft-Versus-Host Disease
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Jakafi a New Treatment Option for Chronic Graft-Versus-Host Disease
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Cabometyx Receives FDA Approval for Differentiated Thyroid Cancer
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Brukinsa Approved for Marginal-Zone Lymphoma and for Waldenström’s Macroglobulinemia
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Nivolumab First Immunotherapy Approved for Adjuvant Treatment of Urothelial Carcinoma
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Jemperli Another Therapy Approved for Patients with dMMR Recurrent or Advanced Solid Tumors
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Lenvima plus Keytruda a New Combination Approved for Advanced Renal-Cell Carcinoma
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Copyright © Green Hill Healthcare Communications, LLC. All rights reserved.