EMA: Imbruvica (ibrutinib) - CHMP opinion estensione di indicazione CLL

Lo scorso 23 Giugno il CHMP ha adottato una positive opinion, per estendere l'indicazione terapeutica del CLL per introdurre la combinazione con venetoclax. Le indicazioni complete inclusive della modifica sono riportate qui di seguito.

Imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

Imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).

Imbruvica as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.

Imbruvica as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo‑immunotherapy. Imbruvica in combination with rituximab is indicated for the treatment of adult patients with WM.

I testi ed EPAR saranno aggiornati successivamente all'approvazione da parte della EC.