Dostarlimab-gxly receives accelerated approval from the FDA for dMMR advanced solid tumours

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August 2021: Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) was given accelerated approval by the Food and Drug Administration for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumours, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

The VENTANA MMR RxDx Panel was also authorised by the FDA today as a companion diagnostic device for patients with dMMR solid tumours who are being treated with dostarlimab-gxly.

The GARNET Experiment (NCT02715284), a non-randomized, multicenter, open-label, multi-cohort trial, looked at the efficacy of dostarlimab. The effectiveness population included 209 patients with dMMR recurrent or advanced solid tumours who had progressed after systemic therapy and had no other options.
Overall response rate (ORR) and duration of response (DoR) were the major efficacy outcomes, as established by blinded independent central review in accordance with RECIST 1.1. With a 9.1 percent complete answer rate and a 32.5 percent partial response rate, the ORR was 41.6 percent (95 percent CI: 34.9, 48.6). The median DOR was 34.7 months (range 2.6 to 35.8+), and 95.4 percent of patients had a DOR of less than 6 months.

Fatigue/asthenia, anaemia, diarrhoea, and nausea are the most prevalent side responses in individuals with dMMR solid tumours (20 percent). Anemia, fatigue/asthenia, elevated transaminases, sepsis, and acute renal injury were the most prevalent Grade 3 or 4 adverse events (2%). Pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and dermatologic toxicity are all immune-mediated adverse events associated with dostarlimab-gxly.

Dostarlimab is given as an intravenous infusion over 30 minutes every three weeks for doses one through four. Dosing is increased to 1,000 mg every 6 weeks starting 3 weeks after dosage 4.

 

Reference: https://www.fda.gov/

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