On 9 February 2023, the US Food and Drug Administration (FDA) approved dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.<\/p>\n
In April 2021, dostarlimab-gxly received accelerated approval for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen.<\/p>\n
Full prescribing information for Jemperli is available here<\/a>.<\/p>\n Efficacy for the regular approval was evaluated in GARNET (NCT02715284), a multicentre, multicohort, open-label study conducted in patients with advanced solid tumours. The efficacy population consisted of a cohort of 141 patients with dMMR recurrent or advanced endometrial cancer who had progressed on or after a platinum-containing regimen. Patients treated with prior PD1\/PD-LI-blocking antibodies, other immune checkpoint inhibitors, or had autoimmune diseases requiring systemic immunosuppressant agents within 2 years were excluded.<\/p>\n The major efficacy outcome measures were overall response rate (ORR) and duration of response (DoR) as assessed by blinded independent central review according to RECIST v1.1. Confirmed ORR was 45.4% (95% confidence interval 37.0, 54.0), with a 15.6% complete response rate and a 29.8% partial response rate. Median DoR was not reached, with 85.9% of patients having durations \u226512 months and 54.7% of patients having durations \u226524 months (range, 1.2+, 52.8+).<\/p>\n The most common adverse reactions (\u226520%) were fatigue\/asthenia, anaemia, rash, nausea, diarrhoea, constipation, and vomiting. Immune-mediated adverse reactions can occur including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, and skin adverse reactions.<\/p>\n The recommended dostarlimab-gxly dose and schedule (doses 1 through 4) is 500 mg every 3 weeks. Subsequent dosing, beginning 3 weeks after dose 4, is 1,000 mg every 6 weeks until disease progression or unacceptable toxicity. Dostarlimab-gxly should be administered as an intravenous infusion over 30 minutes.<\/p>\n This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA\u2019s assessment. The FDA approved this application 1 month ahead of the FDA goal date.<\/p>\n Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA\u2019s MedWatch Reporting System.<\/p>\n For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA\u2019s Oncology Center of Excellence<\/a> Project Facilitate<\/a>.<\/p>\n