FDA Granted Orphan Drug Designation to Utidelone for the Treatment of Pancreatic Cancer
Biostar Pharma, Inc., the US wholly-owned subsidiary of Beijing Biostar Biopharmaceutical Co., Ltd. which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, is pleased to announce that its core pipeline product Utidelone has once again been granted as Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA), for the treatment of pancreatic cancer. This marks the third ODD granted to Utidelone by the FDA, following prior designations for breast cancer brain metastases and gastric cancer.
Share:
More News
“These data underscore gotistobart’s potential to redefine treatment for patients with hard-to-treat squamous NSCLC whose disease has progressed after initial therapy and who face limited options,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “In second- and later lines of treatment, the clinical relevance of novel
“The collaboration with Ratio represents an exciting opportunity to explore the potential of novel radiopharmaceutical approaches designed to address the complexity and heterogeneity of cancer,” said Ben Hickey, President of RayzeBio. “The combination of our respective technologies and complementary development expertise creates a strong foundation for generating a novel differentiated
“We believe these results mark a potentially important step forward in the treatment of EGFR exon 20 insertion mutation-positive non-small cell lung cancer,” said Fabio Benedetti, MD, Global Chief Medical Officer, Taiho Pharmaceutical. “To address the unmet medical needs of patients and their families, we will continue working closely with
“Recent clinical data validated KAT6 as a targetable mechanism in the treatment of HR+/HER2- breast cancer, including those with actionable mutations,” stated Charles Morris, MBChB, MRCP, Chief Medical Officer of Prelude. “Dual KAT6A/B inhibitors, however, demonstrated overlapping toxicities with current backbone therapies that may limit the utility in earlier lines