EMA publishes EPAR for Venclyxto

EMA

22 December 2016 - The EMA has published an EPAR for AbbVie's new BCL inhibitor.

Venetoclax (Venclyxto) was approved by the European Commission on 5 December 2016 for use as:

  • monotherapy for the treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor.
  • monotherapy for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B cell receptor pathway inhibitor

Venetoclax was granted conditional approval and will be subjected to additional monitoring by the EMA.

Read EPAR for venetoclax

Michael Wonder

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Michael Wonder