Last Updated on October 17, 2024 by The Health Master
GlaxoSmithKline (GSK) has announced that the US Food and Drug Administration (USFDA) approved a new indication for Jemperli (dostarlimab-gxly), a programmed cell death receptor-1 (PD-1) blocking antibody, for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours.
The continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s), a statement from the company said.
Speaking on the development, Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, said, “For patients with tumours expressing the dMMR biomarker, there continues to be a significant need for new and effective treatments.
I’m excited about GSK’s second oncology USFDA approval this year, and the new treatment option it provides for these patients.”
The statement also mentioned that the mismatch repair-deficient tumours contain abnormalities that affect the proper repair of DNA when copied in a cell. In the US, the prevalence of dMMR across patients with solid tumours has been estimated at 14 per cent.
The mismatch repair-deficient status is a biomarker that has been shown to predict response to immune checkpoint blockade with PD-1 therapy. Tumours with this biomarker are most commonly found in endometrial, colorectal and other gastrointestinal cancers, but may also be found in other solid tumours.
Lupin gets tentative USFDA nod for Brivaracetam tablets
Zydus Cadila gets USFDA nod for Mesalamine ER capsules
Cipla gets USFDA nod for generic Difluprednate Ophthalmic Emulsion
Alembic gets USFDA nod for Clomipramine HCL Capsules
Zydus Cadila gets final nod from USFDA for Fulvestrant injection
USFDA inspection ends with ‘Zero’ observations: Alkem
FAQs on Legal Metrology & Blood Bags
Latest Notifications regarding Pharmaceuticals
Why to prefer organic emulsifiers over traditional ones ?
Specification of limits for Antibiotic effluents for Drug Industry: Govt
USFDA officials visit FDA Gujarat for information sharing & capacity building
NIAB notified as Central Drugs Laboratory
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
