BioPharma Dive February 10, 2023
Dive Brief:
- The Food and Drug Administration has granted full approval to GSK’s cancer immunotherapy Jemperli in a type of endometrial cancer, the company said Friday, converting an accelerated approval that made the drug the seventh of its type to be cleared for U.S. use.
- The announcement came one day after FDA advisers recommended, in a mixed vote, GSK’s plan to study Jemperli in rectal cancer. GSK proposed a trial that used remission rates after 12 months of treatment as its primary measurement, and will use data from that along with independent research to seek approval.
- Jemperli is used after chemotherapy to treat tumors with a specific genetic error that disrupts cells’ ability to repair DNA in endometrial tissue...
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