The United States of America foremost drug regulator FDA today gave an accelerated approval to the immunotherapy molecule dostarlimab branded as (Jemperli) for the treatment of recurrent or advanced endometrial cancer with deficient mismatch repair (dMMR).
What you should know.
Dortalimab is an inhibitor and its usage is limited to patients who have progressed on or following prior treatment with a platinum-containing chemotherapy. Also the eligibility must be determined by an FDA-approved test for the dMMR biomarker. So basically, the protocol must be strictly adhered to for optimal benefits.
What FDA are saying.
According to FDA Statement made by Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases, “Today’s approval of Jemperli is evidence of the FDA’s progress in applying precision medicine to expand treatment options for patients with cancer, this immunotherapy was specifically studied to target dMMR endometrial cancer and leverages scientific knowledge surrounding the mechanism of immunotherapy response in this unmet medical need population.”
What you must know.
Dostarlimab, a PD-1 inhibitor, recently showcased clinical activity in patients with dMMR and MMR proficient (MMRp) endometrial cancer, regardless of investigator assessment.
In GARNET, investigators tested single-agent dostarlimab in expansion cohorts across multiple tumor types. Patients who were eligible for enrollment were treated with dostarlimab at 500 mg of intravenous (IV) every 3 weeks for 4 cycles followed by 1000 mg IV every 6 weeks until disease progression.
In the data that led to the approval, GSK noted that among 104 patients evaluable for safety, the most common (≥20%) adverse events (AEs) included fatigue (48%), nausea (30%), diarrhea (26%), anemia (24%), and constipation (20%).
The most common (≥2%) grade 3/4 Adverse events included anemia and increase in alanine transaminase levels. Discontinuations of dostarlimab due to Adverse events occurred in 5 (4.8%) of patients, and no drug-related deaths occurred.
This was really an impressive safety profile and we hope that real time market performance could surpass this preliminary findings.
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