FDA approved dostarlimab for dMMR solid tumors

FDA approved dostarlimab for dMMR solid tumors

On 17 August 2021, dostarlimab received United States Food and Drug Administration (US-FDA) accelerated approval to treat adult patients having mismatch repair deficient (dMMR) advanced or recurrent solid tumors (such as colorectal cancer), as assessed by a US-FDA approved test, that have advanced following systemic therapy and who have unsatisfactory alternative therapeutic options.

For selecting people with dMMR solid tumors for dostarlimab therapy, the US-FDA also approved a companion diagnostic device. Dostarlimab’s efficacy was assessed in the GARNET Trial, a multi-cohort, non-randomized, multicenter, open-label trial incorporating 209 participants suffering from dMMR recurrent or advanced solid tumors.

Duration of response and overall response rate were the major efficacy outcomes. Dostarlimab elicited an overall response rate of 41.6%, with a partial response rate of 32.5% and a complete response rate of 9.1%. As found, median duration of response was 34.7 months (range 2.6, 35.8+), with 95.4% of people with duration ≥six months.

Nausea, diarrhea, fatigue /asthenia, and anemia are the most commonly noted adverse reactions (≥20%) in people with dMMR solid tumors. Acute kidney injury, fatigue/asthenia, raised transaminases, sepsis, and anemia were the most common grade 3 or 4 side effects (≥2%). The immune-mediated adverse reactions are also linked with dostarlimab, including dermatologic toxicity, nephritis, pneumonitis, colitis, endocrinopathies, and hepatitis.

Dostarlimab should be intravenously infused over 30 minutes with a suggested dose of dostarlimab of 500 mg every three weeks for doses 1 through 4. Subsequent dosing initiating 3 weeks after dose 4 is about 1000 mg every six weeks.

Also read, Malignant vs Benign Tumor.

SourceUS-FDA
Link:https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dostarlimab-gxly-dmmr-advanced-solid-tumors
Original title of the articleFDA grants accelerated approval to dostarlimab-gxly for dMMR advanced solid tumors

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