On 6 December 2024, AstraZeneca announced that its sBLA for Imfinzi® (durvalumab) has been granted Priority Review by the US FDA for the treatment of patients with muscle-invasive bladder cancer (MIBC).
This follows AstraZeneca’s announcement in August 2024 that the FDA approved Imfinzi® in combination with chemotherapy, for resectable early-stage non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
In November 2024, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation to include an expanded indication of Imfinzi® for the treatment of patients with limited-stage small cell lung cancer.