Prodotti competitors / Area Onco-Ema
Europe: Oncology Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023
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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Imbruvica in combination with bendamustine and rituximab in patients with previously untreated mantle cell lymphoma was withdrawn.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
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