Two Datopotamab Deruxtecan Applications Validated in the EU for Patients with Advanced Nonsquamous NSCLC or HR+, HER2 Negative Breast Cancer
“The EMA validation is an important first step toward bringing this TROP2 directed antibody drug conjugate to eligible patients in Europe with nonsquamous lung cancer and HR positive, HER2 negative breast cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “This news builds on our recent regulatory progress in the U.S., where our lung cancer application has been accepted and our breast cancer application is underway, underscoring our commitment to changing the standard of care by developing new medicines to help as many patients worldwide as possible.”
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CEO Snehal Patel commented, “We are very encouraged to see that the preliminary results from FLAMINGO-01 show immune responses in both HLA-A*02 and non-HLA-A*02 patients. We are now considering the merits of adding a randomized placebo arm for non-HLA-A*02 patients, transforming this current open label third arm into effectively a
“At Ferring, we are committed to meeting the unmet needs in bladder cancer care and equipping uro-oncologists with critical evidence they need to deliver effective, and life-changing treatment,” said Joern Jakobsen, M.D., Ph.D., Vice President and Head of Global Research and Medical for Uro-Oncology and Urology, Ferring Pharmaceuticals. “These new
“We recognise the significance of Mosaic’s platform, which has identified these two assets as anchor components of a pipeline of potential combination products,” said Dr. Harren Jhoti, co-founder, president and chief executive officer of Astex. “Both drug targets are well-characterised drivers of many cancers, and we are excited to be
“We do not view today’s unsatisfactory outcome as a failure of Globo H,” Dr. Heidi Wang, CEO of OBI Pharma added. “There may come a time, with a deeper scientific understanding of the Globo H function, it may play a meaningful role once again.”
