GSK’s Jemperli accepted for FDA review for endometrial cancer treatment
Betsy Goodfellow | April 24, 2024 | News story | Medical Communications | FDA, GSK, Oncology, endometrial cancer, sBLA
GSK has announced that the US Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) to expand its use to the treatment of adult patients with primary advanced or recurrent endometrial cancer. This will now include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours.
The drug is already approved in this combination and as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is either mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).
The FDA has granted the drug Priority Review for the sBLA for its new indication and has assigned a Prescription Drug User Fee Action date of 23 August 2024.
According to the company’s press release, ‘The sBLA is based on results from Part 1 of the RUBY phase 3 trial. The trial met its primary endpoints of investigator-assessed progression-free survival (PFS) and overall survival (OS), demonstrating a statistically significant and clinically meaningful benefit in the overall population of patients treated with dostarlimab plus carboplatin-paclitaxel versus chemotherapy alone. RUBY Part 1 is the only clinical trial to show a statistically significant survival benefit in the overall patient population. The safety and tolerability analysis from RUBY showed a safety profile for dostarlimab and carboplatin-paclitaxel that was generally consistent with the known safety profiles of the individual agents’.
Betsy Goodfellow
Related Content
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
