FDA Commissioner’s National Priority Voucher for BIZENGRI® (Zenocutuzumab-zbco) in NRG1 Fusion-Positive Cholangiocarcinoma
“We are honored to receive this Commissioner’s National Priority Voucher, which reflects the FDA’s recognition of the profound unmet need facing patients with NRG1+ cholangiocarcinoma, an ultra-rare cancer for which no approved targeted therapy currently exists,” said Pritesh J. Gandhi, Chief Development Officer, Partner Therapeutics. “Receiving this voucher highlights the urgent need for new treatment options in NRG1 fusion-positive cholangiocarcinoma. Based on the encouraging data from the eNRGy trial, including meaningful tumor responses, durable benefit and a favorable tolerability profile, we believe BIZENGRI has the potential to address a critical gap in care for these patients. We look forward to working closely with the FDA through this accelerated review process.”
Share:
More News
“The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy
“Patients with non-muscle invasive bladder cancer continue to face a significant risk of disease recurrence despite available treatment options,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “UGN-501 is an investigational next-generation oncolytic virus designed to selectively destroy tumor cells while generating an anti-tumor immune response. FDA clearance of
“Whitehawk has established strong expertise in ADC technology and oncology drug development,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “This collaboration further expands the application of Biocytogen’s fully human bispecific antibodies in ADC development. We look forward to supporting the efficient advancement of multiple programs by contributing high-quality
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The AZUR-1 results support the potential for dostarlimab to transform treatment for dMMR/MSI-H locally advanced rectal cancer. For many patients today, rectal cancer treatment comes with the tolerability burden and lasting impacts from chemotherapy, radiation and surgery. These data