FDA has lifted the partial clinical hold on studies investigating azenosertib developed by Zentalis Pharmaceuticals, a novel WEE1 inhibitor in patients with solid tumors.
This decision allows Zentalis to resume enrolling patients in ongoing clinical trials evaluating azenosertib as a potential treatment for ovarian cancer and other advanced solid tumors.
The partial hold on azenosertib was initiated in June 2024 to allow for further review of safety data following reported events in some patients with solid tumors.
Kimberly Blackwell, CEO of Zentalis Pharmaceuticals, emphasized the gratitude for the FDA’s collaboration and the successful resolution of the partial clinical hold.
She acknowledged their unwavering confidence in azenosertib’s therapeutic potential to address significant unmet needs in gynecologic malignancies.
Zentalis submitted a response to the FDA on azenosertib, which led to approval for continuing studies without changes, and will now work with clinical trial investigators to restart patient recruitment for solid tumors across its development program.
Additionally, the company planned to present azenoserti monotherapy data and provide updates on its clinical development program later this year.
Source: Zentalis Pharmaceuticals Announces FDA Has Lifted Partial Clinical Hold on Azenosertib Studies
https://ir.zentalis.com/news-releases/news-release-details/zentalis-pharmaceuticals-announces-fda-has-lifted-partial
