The blood cancer drug acalabrutinib has been approved by the FDA in a film-coated tablet formulation for patients. Acalabrutinib was previously approved for use in capsule form for the treatment of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and previously treated relapsed or refractory mantle cell lymphoma (MCL). The new tablet formulation will benefit patients who were previously unable to take the capsule form.
According to the American Cancer Society, CLL/SLL accounts for about one-quarter of new leukemia cases in the United States. Acalabrutinib is a type of Bruton tyrosine kinase inhibitor that works by blocking the actions of abnormal proteins that signal cancer cells to multiply. The drug was studied in the ELEVATE-TN trial, in which it was found to be highly effective with or without the addition of obinutuzumab for treating treatment-naïve CLL. Four-year follow-up results also demonstrated continued efficacy and low rates of treatment discontinuation in the trial group. Acalabrutinib also showed flexibility as both a monotherapy or combination treatment, and can be used in conjunction with obinutuzumab for CLL.
MCL occurs more often in older adults, and is found in about one in 200,000 people per year. As found in the ACE-LY-004 study, acalabrutinib was shown to have an 81% response rate in MCL patients, with 26-month follow-up results demonstrating the continued efficacy and favorable safety profile of the drug. Nearly half of all study patients remained progression-free after two years of treatment with acalabrutinib.
Results from the ELEVATE-PLUS clinical trials led to the FDA’s decision to approve the tablet form of acalabrutinib. The trial compared acalabrutinib 100 mg tablets to the 100 mg capsules. The tablet formulation was found to be equivalent to capsules, with both forms sharing similar efficacy and safety profiles. The introduction of acalabrutinib in a tablet form will benefit patients who were previously unable to take the medication in capsule form.
The capsule form of acalabrutnib was not utilized effectively with the simultaneous use of acid-reducing medications, including proton pump inhibitors, H2-receptor antagonists, and antacids. These medications could lead to reduced effectiveness of acalabrutnib. Capsules may also be harder for some patients to swallow, leading to alternative forms of administration, such as oral suspensions or nasogastric tubes. The newly-approved film-coated tablet formulation has an immediate release and can be used alongside the aforementioned medications, and also has a high safety profile with minimal adverse effects.
“Patients with blood cancers like chronic lymphocytic leukemia and mantle cell lymphoma are often older and may face multiple medical conditions that may need intervention, including acid reflux or peptic ulcer disease. The US approval of acalabrutinib in a tablet form enables co-administration of the acalabrutinib tablet alongside a proton pump inhibitor. This provides another option for some patients with chronic lymphocytic leukemia and relapsed or refractory mantle cell lymphoma, enabling more patients to potentially benefit from this treatment,” John C. Byrd, MD, chair of the Department of Internal Medicine at the University of Cincinnati, said in a press release.
FDA Approves Acalabrutinib Tablet Formulation in CLL/SLL and Relapsed/Refractory MCL