FDA Approves BIZENGRI® (Zenocutuzumab-zbco) for NRG1 Fusion-Positive Cholangiocarcinoma Following Receipt of FDA Commissioner’s National Priority Voucher
“Today’s FDA approval of BIZENGRI for NRG1 fusion-positive cholangiocarcinoma is a historic milestone for patients who have had no approved targeted therapy. We thank the patients, their families, and the investigators for their participation in the eNRGy trial. The results demonstrate meaningful tumor responses, durable benefit, and a favorable tolerability profile—and we are grateful that the FDA’s Commissioner’s National Priority Voucher pilot program greatly reduced the review time, helping bring this treatment to patients more quickly. We look forward to working with the oncology community to ensure appropriate patients can access BIZENGRI without delay.”
Share:
More News
Alistair Henry, Executive Vice President & Chief Scientific Officer at UCB said, “Partnering with CRUK’s Centre for Drug Development and Cancer Research Horizons allows us to harness their world-class oncology expertise and clinical insights, complementing UCB’s strengths in discovery and development. This collaboration is a testament to the power of
“We are excited to write the next chapter of Cytospire’s story with this fantastic group of specialist investors,” said Natalie Mount, Chief Executive Officer of Cytospire Therapeutics. “Immune cell engagers are an important type of cancer immunotherapy, but we know that there are significant limitations from both an efficacy and
“This financing represents an important milestone for Signadori Bio as we continue to build on our promising preclinical data and advance our platform toward the clinic. Our approach to in vivo engineering of monocytes has the potential to unlock a new class of immunotherapies that are more accessible, scalable, and
“We are thrilled to have the support of top-tier investors who believe in inobrodib’s potential to address a critical need in multiple myeloma, notably after bispecific T cell engager or anti-BCMA therapies. This is a significant and growing unmet need,” said Will West, Ph.D., CEO of CellCentric. “Inobrodib is a