DATROWAY Supplemental NDA Submitted in Japan for Patients with Metastatic TNBC Who Are Not Candidates for Immunotherapy
“Metastatic triple negative breast cancer is highly aggressive and has one of the worst prognoses of any subtype of breast cancer,” said Yuki Abe, PhD, Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. “We are working as quickly as possible with the Japan health authority to make DATROWAY the first TROP2 directed antibody drug conjugate to become available in Japan for first-line triple negative breast cancer, addressing the unmet need for the seventy percent of patients in this setting who are not candidates for immunotherapy.”
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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.
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Mabwell, an innovation-driven biopharmaceutical company with a fully integrated industry chain, today announced that the first patient has been dosed in a Phase III clinical trial evaluating its novel Nectin-4-targeting ADC (Bulumtatug Fuvedotin, or BFv, R&D code: 9MW2821) for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC).