Oncology: CHMP meeting highlights Dicembre 2022

Sono disponibili qui gli highlights per il meeting del CHMP di Dicembre 2022.

New medicines recommended for approval 

Imjudo (tremelimumab) - AstraZeneca AB 

• Used in combination with Imfinzi (durvalumab) for the treatment of adults with hepatocellular carcinoma, a type of liver cancer. 
• Committee adopted a positive opinion.

Tremelimumab AstraZeneca (tremelimumab) - AstraZeneca AB 

• For the treatment of metastatic non-small-cell lung cancer in combination with Imfinzi (durvalumab) and platinum-based chemotherapy. 
• Committee adopted a positive opinion. 

Negative opinion for one new medicine 

Omblastys (iodine (131I) omburtamab) - Y-Mabs Therapeutics A/S 

• The treatment of neuroblastoma, a rare type of cancer.
• The CHMP recommended the refusal of a marketing authorization. 

Recommendations on extensions of therapeutic indication  

Enhertu (trastuzumab deruxtecan) – Daiichi Sankyo Europe GmbH 

•  the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. 

Imfinzi (durvalumab) – AstraZeneca AB 

• 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 chemoradiation therapy.