Calquence Approved for CLL

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Calquence. The CHMP adopted a new indication to include treatment of adults with previously untreated chronic lymphocytic leukaemia in combination with venetoclax.

 The full indications for Calquence will therefore be as follows: Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Calquence in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Under the updated authorization, Calquence can now be prescribed as a single therapy or alongside obinutuzumab for adults facing their first-line CLL treatment. Additionally, the combination of Calquence with venetoclax, with or without obinutuzumab, is approved for the same patient demographic.