PT217 receives Orphan Drug Designation for Neuroendocrine Carcinoma from the FDA
“PT217 was granted ODD for the treatment of SCLC by the FDA in 2022 and granted Fast Track designation by the agency in 2024 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor. Earlier this year, Phanes entered into a clinical supply agreement with Roche to study PT217 in combination with Roche’s anti-PD-L1 therapy, atezolizumab.”
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“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”
“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.