Durvalumab (Imfinzi®): CHMP Positive Opinion for NSCLC in Europe

Durvalumab (Imfinzi®): CHMP Positive Opinion for NSCLC in Europe

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. [1] Continue reading “Durvalumab (Imfinzi®): CHMP Positive Opinion for NSCLC in Europe”

Durvalumab (Imfinzi™): First Global Approval – Empower the host – disarm the disease; immune-stimulation brings hope in bladder cancer

Durvalumab (Imfinzi™): First Global Approval – Empower the host – disarm the disease;  immune-stimulation brings hope in bladder cancer

The recent first global approval of durvalumab has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1] based on the development milestones tracked in AdisInsight.[2] Continue reading “Durvalumab (Imfinzi™): First Global Approval – Empower the host – disarm the disease; immune-stimulation brings hope in bladder cancer”

Avelumab (Bavencio®): First Global Approval – Inaugural Immunotherapy for Metastatic Merkel Cell Carcinoma

Avelumab (Bavencio®): First Global Approval – Inaugural Immunotherapy for Metastatic Merkel Cell Carcinoma

The recent first global approval of avelumab has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

Continue reading “Avelumab (Bavencio®): First Global Approval – Inaugural Immunotherapy for Metastatic Merkel Cell Carcinoma”