Cinetredekin besudotox Granted FDA Orphan Drug Designation by US FDA for Treatment of GBM
“Receiving Orphan Drug Designation is an important milestone for Precision NeuroMed as we advance our mission to transform treatment for patients with glioblastoma, one of the most aggressive and devastating brain cancers,” said Sandeep Kunwar, MD, CEO and Co-Founder, Precision NeuroMed. “By combining innovative drugs with our next-generation delivery system, we hope to dramatically improve outcomes where few effective options currently exist.”
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“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
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