Acalabrutinib
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Chronic lymphocytic leukaemia4 | |||
None | + obinutuzumab | 1L | None |
None | + venetoclax with or without obinutuzumab | 1L | None |
None | Monotherapy | 1L | None |
None | Monotherapy | 2L | After at least one prior therapy |
| Mantle cell lymphoma2 | |||
None | + bendamustine and rituximab | 1L | Not eligible for autologous stem cell transplant (ASCT) |
None | Monotherapy | 2L | No prior BTK inhibitor |
Full text of section 4.1 (therapeutic indications)
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). Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy. Calquence in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT). Calquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a BTK inhibitor.
Label history
15 changes to the Calquence label since 2022, 3 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes