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IMBRUVICA Janssen-Cilag Pty Ltd
Product name
IMBRUVICA
Sponsor
Accepted date
Sep-2025
Active ingredients
ibrutinib
Proposed indication
The proposed uses for Imbruvica (ibrutinib) include:
Mantle cell lymphoma (MCL)
-after prior treatment: Used alone in adults who’ve already had treatment.
-First-time treatment: Used with other anti-cancer medicines for adults who are eligible for a stem cell transplant.
Waldenström’s macroglobulinaemia (WM), used alone for adults who:
-have had previous treatment, or
-are unsuitable for chemo-immunotherapy.
-also used rituximab.
Chronic lymphocytic leukaemia / small lymphocytic lymphoma (CLL/SLL)
-for adults who haven’t been treated before, it can be used alone or with rituximab, binutuzumab, or venetoclax.
-for adults who’ve had prior treatment, can be used alone or with bendamustine and rituximab.
Mantle cell lymphoma (MCL)
-after prior treatment: Used alone in adults who’ve already had treatment.
-First-time treatment: Used with other anti-cancer medicines for adults who are eligible for a stem cell transplant.
Waldenström’s macroglobulinaemia (WM), used alone for adults who:
-have had previous treatment, or
-are unsuitable for chemo-immunotherapy.
-also used rituximab.
Chronic lymphocytic leukaemia / small lymphocytic lymphoma (CLL/SLL)
-for adults who haven’t been treated before, it can be used alone or with rituximab, binutuzumab, or venetoclax.
-for adults who’ve had prior treatment, can be used alone or with bendamustine and rituximab.
Application type
C (new indication)
Publication date
Sep-2025