Update on FDA Advisory Committee vote on Lynparza plus abiraterone for metastatic CRPC
Neal Shore, Chief Medical Officer of Urology and Surgical Oncology for Genesis Care, US and PROpel trial investigator, said: “Today’s recommendation by the ODAC is disappointing news for clinicians and prostate cancer patients alike. Preventing or delaying radiographic progression is an important clinical endpoint in assessing oncologic treatment and is very relevant to patients, their caregivers and their families. It is essential that physicians and patients have an opportunity to choose treatment with the goal of optimising cancer care outcomes.”
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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.