Zovegalisib Granted Breakthrough Therapy Designation by FDA for PIK3CA-mutant, HR+/HER2- Advanced Breast Cancer
“Approximately 40% of patients with HR+/HER2- advanced breast cancer harbor PIK3CA mutations, and most experience disease recurrence or progression following treatment with CDK4/6 inhibitors, leaving limited therapeutic options,” said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. “This Breakthrough Therapy designation underscores the FDA’s recognition of the potential of zovegalisib in combination with fulvestrant to meaningfully improve outcomes for these patients, reinforcing the impact of the encouraging clinical evidence we have demonstrated to date. We look forward to continuing to collaborate closely with the FDA as we work to advance this program as efficiently as possible for patients.”
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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.”
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