Applications Submitted For Rubraca® Label Expansion In The US And EU As 1L Maintenance Treatment In Advanced Ovarian Cancer Patients
“We believe the compelling PFS results, the primary endpoint of the ATHENA-MONO trial, are strongly supportive of an approval and reinforce the potential of Rubraca as an important new first-line maintenance treatment for ovarian cancer,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We are grateful to the patients who participated in the trial and for the support of the clinical community familiar with these results.”
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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.