Prodotti competitors / Area Onco-Ema
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.
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