FDA Approves Second Drug Under New International Network Pathway for CLL/SLL

The U.S. Food and Drug Administration (FDA) granted supplemental approval to Calquence® (acalabrutinib) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma.

The FDA, along with the Australian Therapeutic Goods Administration and Health Canada, approved this combination through Project Oribis, a new international framework for concurrent submission and review of oncology drugs. Project Orbis only applies to supplemental oncology approvals or approvals for new indications of previously approved therapies, not new drug applications. The first approval under Project Oribis occurred in September for Lenvima® (lenvatinib) plus Keytruda® (pembrolizumab) for the treatment advanced endometrial carcinoma

Improved survival with acalabrutinib versus other standard treatments

The approval was based on results from two randomized clinical trials that compared acalabrutinib versus other standard treatments. The first study—the ELEVATE-TN trial—included 535 patients with previously untreated CLL. Patients receiving acalabrutinib had longer progression-free survival (PFS) than those receiving other standard treatments. The second study—the phase III ASCEND trial—included 310 patients with previously treated CLL. Patients received acalabrutinib or physician’s choice of idelalisib plus rituximab or bendamustine plus rituximab. Acalabrutinib prolonged PFS compared with the other treatments.

The most common adverse events associated with acalabrutinib include anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain.

During treatment with acalabrutinib, patients should be monitored for atrial fibrillation and flutter, serious infections, bleeding, and low blood counts.

Patients receiving acalabrutinib should use sun protection, as skin cancers and other solid tumors, can occur.

Women who are pregnant or breastfeeding should not take acalabrutinib.