Calquence (acalabrutinib)
- Region
- 🇪🇺 EU
- Active substance
- acalabrutinib
- Company
- AstraZeneca AB
- Status
- Authorised
- Therapeutic area
- Leukemia, Lymphocytic, Chronic, B-Cell
- CHMP opinion
- Thu 05 Nov 2020
- EU approval
- Thu 05 Nov 2020
- Application
- EMEA/H/C/005299
- ATC
- L01EL02
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.