Is Calquence Approved for Mantle Cell Lymphoma?
Yes, Calquence (acalabrutinib) is FDA-approved to treat mantle cell lymphoma (MCL) in adults who have received at least one prior therapy.[1] The agency granted accelerated approval in October 2017 based on overall response rates from a phase 2 trial, later converted to full approval in 2021 after confirmatory data showed durable responses.[2]
How Does Calquence Work in MCL?
Calquence is a Bruton's tyrosine kinase (BTK) inhibitor that blocks signaling in B-cell malignancies like MCL. It targets the CD19-positive cells driving lymphoma growth, leading to tumor shrinkage in about 80% of relapsed/refractory MCL patients, with 40% achieving complete responses.[2] Unlike broader BTK inhibitors like Imbruvica (ibrutinib), Calquence shows higher selectivity, potentially reducing off-target effects like atrial fibrillation.[3]
Who Qualifies for Calquence in MCL?
Treatment is for relapsed or refractory MCL after at least one prior line of therapy, such as chemotherapy or stem cell transplant. It's not approved for frontline use in MCL, though trials are exploring that. Dosing is 100 mg orally twice daily until disease progression or toxicity.[1]
What About Other Approvals for Calquence?
Beyond MCL, Calquence treats chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in first-line or relapsed settings, often with obinutuzumab. Ongoing trials test it in combinations for MCL and other B-cell lymphomas.[2]
Common Side Effects in MCL Patients
Patients report infections (50%), bleeding (45%), anemia (30%), and neutropenia (25%). Cardiac events like atrial fibrillation occur less often than with ibrutinib (about 5% vs. 10-15%). Monitor for bleeding risks, especially with anticoagulants.[1][2]
How Does It Compare to Imbruvica for MCL?
Both are BTK inhibitors approved for relapsed MCL, but Calquence has shown higher progression-free survival in head-to-head CLL trials (not directly in MCL) and fewer heart-related discontinuations. Imbruvica has broader frontline approvals in MCL.[3]
| Aspect | Calquence | Imbruvica |
|--------|-----------|-----------|
| MCL Approval | Relapsed/refractory | Frontline + relapsed |
| Atrial Fibrillation Rate | ~5% | 10-15% |
| Response Rate in Relapsed MCL | ~80% | ~70% |
When Does Calquence's Patent Expire?
Key U.S. patents on acalabrutinib expire in 2033-2034, with pediatric exclusivity potentially extending to 2035. Challenges from generics like those from MSN and Dr. Reddy's are pending; no biosimilars yet as it's a small molecule.[4]
Ongoing Trials and Future for MCL?
Phase 3 trials combine Calquence with rituximab or venetoclax for relapsed MCL, aiming for frontline approval. Early data show deeper responses than monotherapy.[2]
Sources
[1]: FDA Label for Calquence
[2]: AstraZeneca Press Release on MCL Approval
[3]: NEJM: Acalabrutinib vs Ibrutinib in CLL (ELEVATE-TN)
[4]: DrugPatentWatch.com - Acalabrutinib Patents