Update on U.S. Regulatory Review of TALZENNA in Combination with XTANDI for Broader Use in Metastatic CRPC Provided
“Men with metastatic castration-resistant prostate cancer are often faced with a poor prognosis and limited treatment options, and TALZENNA in combination with XTANDI has redefined the standard-of-care for patients living with HRR gene-mutated mCRPC,” said Johanna Bendell, M.D., Oncology Chief Development Officer, Pfizer. “We are pleased that the statistically significant final overall survival data reaffirming the current indication has been added to the label, based on the strong results from TALAPRO-2.”
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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.