In July 2018 durvalumab (Imfinzi ®) received a positive opinion from the Committee for Medical Products for Human Use (CHMP). The committee recommended marketing authorisation for the agent in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells, and whose disease has not progressed following platinum-based chemotherapy and radiation therapy.  Continue reading “Durvalumab (Imfinzi®): CHMP Positive Opinion for NSCLC in Europe”
In February 2018, durvalumab (IMFINZI®) was approved in the US for the treatment of patients with unresectable, stage III non-small cell lung cancer (NSCLC), whose cancer has not progressed after chemoradiation therapy. Continue reading “Durvalumab (IMFINZI®): Follow up Approval for NSCLC, a second indication, in USA”
The recent first global approval of durvalumab in the US has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs, based on the development milestones tracked in AdisInsight.
In November, 2017, durvalumab (Imfinzi™), developed by AstraZeneca via Medimmune, was also approved in Canada for the treatment of advanced bladder cancer (late stage and/or metastatic disease) as monotherapy in previously treated patients (second-line or greater). Continue reading “Durvalumab (IMFINZI®): Follow up Approval in Canada”