GlaxoSmithKline PLC (LON:GSK) said the US Food and Drug Administration (FDA) has approved its treatment for adults with recurrent or advanced endometrial cancer.
JEMPERLI (dostarlimab-gxly) is an antibody that blocks the interaction between the PD-1 receptor with two other proteins that suppress the immune system.
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This indication is approved under accelerated approval based on tumour response rate and durability of response, the pharma giant said, so continued approval may depend on results of confirmatory trials.
The trial showed an overall response rate of 42.3% and a duration of response of six months or more for 93.3% of participants.
Around one in four people with endometrial cancer may experience a recurrence or be diagnosed with advanced disease.
For those whose disease recurs after platinum-based chemotherapy, there is generally no accepted standard of care.
Additionally, endometrial cancer has the highest rate of deficient mismatch repair (dMMR) among tumour types, at approximately 25%, and increased rates of recurrence have been reported for patients with dMMR endometrial cancer.
JEMPERLI has been designed with people with dMMR.
The FTSE 100 firm is also studying dostarlimab for endometrial cancer in earlier treatment lines and in combination with other therapeutic agents for patients with advanced solid tumours or metastatic cancer.
"Unfortunately, as many as 60,000 women are diagnosed with endometrial cancer in the US each year and these women currently have limited treatment options if their disease progresses on or after first-line therapy,” said Hal Barron, chief scientific officer and president of R&D at GSK.
“Today's approval of dostarlimab by the FDA has the potential to transform the treatment landscape for these women and demonstrates our continued commitment to helping patients with gynecologic cancers."