Mersana Therapeutics Reports US FDA’s Partial Clinical Hold on New Patient Enrollment of UpRi for Platinum-Sensitive Ovarian Cancer
Shots:
- The US FDA has placed a partial clinical hold on new patient enrollment in the (UP-NEXT) and (UPGRADE-A) evaluating UpRi in patients with Pt-sensitive ovarian cancer
- The decision was based on the data which showed a higher rate of serious bleeding events in treated patients with Pt-resistant ovarian cancer & 5 cases of serious bleeding were fatal. Patients already enrolled can continue treatment
- The patient enrollment has been completed in the (UPLIFT) trial of UpRi for Pt-resistant ovarian cancer with results expected by early August. The company intends to work with the US FDA to lift the partial clinical hold and restart enrollment in (UP-NEXT) and (UPGRADE-A) trial
Ref: Globenewswire | Image: Mersana
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