ASTRAZENECA — Calquence FDA Review (NDA/BLA 210259, 2020)
AstraZeneca PLC · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved CALQUENCE (acalabrutinib) capsules for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in November 2019, building on its prior accelerated approval for mantle cell lymphoma (MCL). This approval, based on the ASCEND and ELEVATE-TN trials, demonstrated CALQUENCE's significant improvements in progression-free survival and overall response rates compared to standard treatments. The drug exhibits a consistent safety profile, with common adverse reactions including cardiac events, cytopenias, and infections. Pharmacokinetic data supports a 100 mg BID dosing regimen, though use in severe hepatic impairment is not recommended. Regulatory reviews confirmed a favorable benefit-risk assessment, with no need for a REMS, and the FDA agreed with extending the indication to SLL due to its similarity to CLL.
Key findings — cited to the page
| Anemia (all grades, MCL) | 46 % | CALQUENCE · p.15 |
| Grade 3 or 4 lymphopenia | 7 % | CALQUENCE · p.13 |
| Grade 3 atrial fibrillation or flutter | 1.1 % | CALQUENCE · p.13 |
| All grades of atrial fibrillation or flutter | 4.1 % | CALQUENCE · p.13 |
| Grade 3 or 4 anemia | 8 % | CALQUENCE · p.13 |
| Grade 3 or 4 thrombocytopenia | 7 % | CALQUENCE · p.13 |
| Bleeding events of any grade (excluding bruising and petechiae) | 22 % | CALQUENCE · p.12 |
| Grade 4 neutropenia | 12 % | CALQUENCE · p.13 |
| Major hemorrhage (serious or Grade 3 or higher bleeding or any central nervous system bleeding) | 3.0 % | CALQUENCE · p.12 |
| Serious or Grade 3 or higher infections | 19 % | CALQUENCE · p.12 |
| Grade 3 or 4 neutropenia | 23 % | CALQUENCE · p.13 |
| Anemia (Grade >=3, MCL) | 10 % | CALQUENCE · p.15 |
Source: AstraZeneca PLC ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →