Zentails’ Azenosertib Receives FDA Fast Track Designation For Treating PROC

Zentalis® Pharmaceuticals, Inc., a biopharmaceutical company advancing innovative small molecule therapies for cancer, has announced that the FDA has granted Fast Track Designation to azenosertib. This designation is specifically for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (PROC) who test positive for elevated Cyclin E1 protein levels via immunohistochemistry.

Ingmar Bruns mentioned, "Zentalis is sharply focused on our goal of bringing azenosertib to patients with gynaecological malignancies. The FDA’s decision to grant Fast Track Designation for azenosertib in Cyclin E1 positive ovarian cancer patients underscores the unmet medical need in this patient population, which has historically been associated with resistance to chemotherapy and poor patient outcomes. This designation provides meaningful benefits, including those that may expedite the regulatory review of this product candidate in this patient population. We look forward to sharing updated azenosertib clinical data and a regulatory update, including plans for registration-intent studies, at our corporate event on January 29.”

Fast Track designation is granted to those drugs that have potential to address serious diseases and to provide significant improvement where unmet need is identified and recognised, and to enable a faster development and review. Recently, Zentalis’ researchers presented the article in npj Precision Oncology where they demonstrated that Cyclin E1/CDK2 activation serves as an important biomarker to evaluate a patient's response to azenosertib. This research underscores the potential of azenosertib in precision oncology.

Mark Lackner, Chief Scientific Officer, commented, “The data in this manuscript provide functional and mechanistic demonstration that preclinical models with high levels of Cyclin E1 activation are particularly sensitive to azenosertib inhibition, along with supporting clinical data from select patients enrolled in azenosertib clinical studies. We believe these data support a biomarker-directed strategy to identify patients most likely to benefit from azenosertib.”