The US Food and Drug Administration (FDA) has approved a new indication for GlaxoSmithKline’s (GSK) Jemperli (dostarlimab) for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours.
The FDA has cleared the programmed death receptor-1 (PD-1) blocking antibody for patients whose cancer has progressed following prior treatment, and who have no alternative treatment options.
This indication was approved under accelerated approval based on tumour response rate and durability of response.
The GARNET study demonstrated an objective response rate of 41.6% across dMMR solid tumours, and 95.4% of patients maintained a response for six months or longer.
This is the second FDA approved indication for Jemperli in 2021, GSK added in a statement.
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 FDA approval this year, and the new treatment option it provides for these patients.”
Under the accelerated approval pathway, continued approval for Jemperli in this indication could be dependent on ‘verification and description’ of clinical benefit in a further confirmatory trial.
GSK is also studying Jemperli in earlier treatment lines for endometrial cancer as well as in combination with other therapies for patients with advanced/metastatic cancers aside from endometrial cancer.