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FDA Approvals, News & UpdatesImmunotherapy

Jemperli a New Immunotherapy Approved for All Patients with dMMR Solid Tumors

On August 17, 2021, the FDA accelerated the approval of Jemperli (dostarlimab-gxly; from GlaxoSmithKline) injection, an immunotherapy and a PD-1 inhibitor, for the treatment of all adults with recurrent (coming back) or advanced mismatch repair-deficient (dMMR) solid tumors, including lung cancer, that progressed during or after systemic therapy and for whom there are no satisfactory alternative treatment options.
Web Exclusives – December 14, 2021

On August 17, 2021, the FDA accelerated the approval of Jemperli (dostarlimab-gxly; from GlaxoSmithKline) injection, an immunotherapy and a PD-1 inhibitor, for the treatment of all adults with recurrent (coming back) or advanced mismatch repair-deficient (dMMR) solid tumors, including lung cancer, that progressed during or after systemic therapy and for whom there are no satisfactory alternative treatment options.

Patients have to undergo the FDA-approved test VENTANA MMR RxDx Panel, which was approved on the same day as a companion diagnostic test for the identification of patients with dMMR solid tumors who are candidates to receive treatment with Jemperli.

The FDA approved Jemperli for this indication based on a non-randomized clinical trial of 209 patients with dMMR recurrent or advanced solid tumors that progressed during or after systemic therapy.

The overall response rate to Jemperli therapy was almost half (41.6%), which included 9.1% complete responses (meaning the patients had no sign of cancer detected). On average, in most patients (95.4%) the response to treatment with Jemperli lasted 6 months or longer.

The most common serious side effects (grade 3 or 4) in this study were anemia, fatigue, some elevated blood levels, infections, and acute kidney injury. Immune-related side effects with Jemperli were several types of infection, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, as well as skin side effects.

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Last modified: March 10, 2022

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