Europe: Oncology Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023

On the 27th of January 2023, CHMP released its meeting highlights for the month of January. The main discussion points of the meeting are as follows: 

Recommendations on extensions of therapeutic indication 

Nubeqa (darolutamide) - Bayer AG 

• Indication: a medicine used to treat men with prostate cancer, with high risk of metastasis. 
• The committee recommended extension of indication. 

Withdrawals of applications 

Imbruvica (ibrutinib) - Janssen-Cilag International N.V. 

• Indication: a medicine used to treat certain blood cancers involving B cells such as Chronic lymphocytic leukaemia. 
• The application to extend the therapeutic indication of Imbruvica in combination with bendamustine and rituximab in patients with previously untreated mantle cell lymphoma was withdrawn. 

Notification Link: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023