Jemperli Another Therapy Approved for Patients with dMMR Recurrent or Advanced Solid Tumors

Web Exclusives - FDA Approvals

On August 17, 2021, the FDA accelerated the approval of dostarlimab-gxly (Jemperli; GlaxoSmithKline) for adults with mismatch repair-deficient (dMMR), as determined by an FDA-approved test, recurrent or advanced solid tumors that progressed during or after treatment for whom there are no satisfactory alternative options.

On the same day, the FDA also approved the VENTANA MMR RxDx Panel as a companion diagnostic test to select appropriate candidates for dostarlimab therapy. Dostarlimab was initially approved in April 2021 for endometrial cancer.

The FDA approval of dostarlimab for this indication was based on the GARNET study, a nonrandomized, multicenter, open-label, multicohort clinical trial of 209 patients with dMMR recurrent or advanced solid tumors that progressed after systemic therapy.

The primary end points were overall response rate (ORR) and duration of response (DOR). The ORR was 41.6%, including 9.1% complete responses and 32.5% partial responses. The median DOR was 34.7 months; 95.4% of the patients had a response lasting ≥6 months.

The most common (≥2%) grade 3 or 4 adverse events were anemia, fatigue/asthenia, increased transaminases, sepsis, and acute kidney injury. Immune-mediated adverse reactions associated with dostarlimab include pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and dermatologic toxicity.

Related Items
Yescarta First CAR T-Cell Therapy FDA Approved for Large B-Cell Lymphoma
Web Exclusives published on July 29, 2022 in FDA Approvals
Tibsovo Received a New Indication, in Combination with Azacitidine, for Newly Diagnosed Patients with AML and IDH1 Mutation
Web Exclusives published on July 22, 2022 in FDA Approvals
Kymriah Received Accelerated FDA Approval for Relapsed or Refractory Follicular Lymphoma
Web Exclusives published on July 19, 2022 in FDA Approvals
Vidaza Received New Indication for Patients with Newly Diagnosed Juvenile Myelomonocytic Leukemia
Web Exclusives published on July 19, 2022 in FDA Approvals
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
Last modified: December 14, 2021
Copyright © Engage Healthcare Communications, LLC. All rights reserved.