GSK's endometrial cancer treatment receives full FDA approval

Drugmaker GSK's mismatch repair-deficient recurrent or advanced endometrial cancer treatment has been granted full approval by the Food and Drug Administration.

GSK said Jemperli's approval comes hot on the heels of long-term outcome results from its GARNET phase I trial, which demonstrated an overall response rate of 45.4%.

The FTSE 100-listed firm stated 85.9% of patients had duration of response in less than 12 months and 54.7% of patients had duration of response in less than 24 months.

The FDA's Oncologic Drugs Advisory Committee voted eight to five in support of the question posed to the committee regarding whether data from two proposed single-arm trials will be "sufficient to characterise the benefits and risks" of the drug.

Hesham Abdullah, head of oncology development at GSK, said: "This US regulatory action confirms our confidence in Jemperli as an important treatment option for patients with dMMR recurrent or advanced endometrial cancer.

"We continue to unlock the potential of Jemperli as the backbone for our immuno-oncology development programmes to address the unmet needs of patients, including earlier lines of endometrial cancer and other solid tumours."

Reporting by Iain Gilbert at Sharecast.com