AstraZeneca announced that the FDA accepted for Priority Review its supplemental New Drug Application (sNDA) for Tagrisso® (osimertinib) in combination with chemotherapy has been accepted and granted Priority Review in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The FDA expects to decide on the sNDA by Q1 2024.
Last month on 5 September 2023, AZ announced that the Chinese National Medical Products Administration approved its Calquence® (acalabrutinib) to treat a new indication: chronic lymphocytic leukaemia or small lymphocytic lymphoma who have received at least one prior therapy.