CHMP Agenda March 2022

Sul sito istituzionale EMA è stato reso disponibile il documento riepilogativo del CHMP (Committee for Medicinal Products for Human Use) svoltosi il 21-24 Marzo 2022.

Vi segnaliamo che sono in corso le seguenti procedure:

- Enhertu (trastuzumab deruxtecan): estensione di indicazione "to include treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens".

- Imbruvica (ibrutinib):  estensione di indicazione esistente per CLL  "to include combination treatment with venetoclax for previously untreated patients based on efficacy and safety data from phase 3 study GLOW and phase 2 study CAPTIVATE".

- Keytruda (pembrolizumab): estensione di indicazione  "to include a new indication for Keytruda, in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent, or metastatic cervical cancer in adults". 

- Tecentriq (atezolizumab): estensione di indicazione "to include adjuvant treatment of non-small cell lung cancer (NSCLC) following resection and platinum-based chemotherapy for adult patients whose tumours have PD-L1 expression on ≥ 1% of tumour cells (TC) for Tecentriq as monotherapy based on the results from the pivotal phase III study GO29527 (IMpower010)"