US FDA Grants Priority Review to TEVIMBRA in 1L HER2+ GEA
Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, BeOne Medicines, said: “HERIZON‑GEA‑01 has the potential to shift the treatment paradigm in this historically difficult-to-treat disease, with the TEVIMBRA-containing arm demonstrating an unprecedented 26-month survival benefit. The FDA’s Priority Review designation is a major milestone in our effort to bring better first‑line options to patients with HER2‑positive gastroesophageal adenocarcinoma. We will work in partnership with regulators to support the review process, with the aim of rapidly bringing this new treatment option to patients.”
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