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The FDA has approved a new tablet formulation of acalabrutinib for all current indications, including adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and for those with relapsed or refractory mantle cell lymphoma.
The FDA has approved a new tablet formulation of acalabrutinib (Calquence) for all current indications, including adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and for those with relapsed or refractory mantle cell lymphoma (MCL).
The regulatory decision was supported by data from the ELEVATE PLUS trials, in which the capsule and tablet formulations of the drug were determined to be bioequivalent, indicative that the same safety and efficacy can be expected from either formulation when using the same dose and schedule.
Notably, the tablet formulation can be taken with gastric acid-reducing agents, including proton pump inhibitors, antacids, and H2-receptor antagonists.
Moreover, most of the toxicities reported in these studies were noted to be mild. No new safety signals were observed with the tablet vs the capsule formuation of acalabrutinib.
“Patients with blood cancers like CLL and MCL are often older and may face multiple medical conditions that may need intervention, including acid reflux or peptic ulcer disease," John C. Byrd, MD, chair of the Department of Internal Medicine at the University of Cincinnati, stated in a press release. "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 CLL and relapsed or refractory MCL, enabling more patients to potentially benefit from this treatment.”
The three phase 1, open-label, single-dose, crossover studies were conducted in healthy patients to determine the pharmacokinetic (PK) similarity of the acalabrutinib tablet given at 100 mg vs the capsules given at 100 mg (n = 66).
Investigators also wanted to examine the proton pump inhibitor effect by comparing the PK of the tablet formulation in the presence or absence of rabeprazole (n = 14), as well as the food effect by comparing PK of 100 mg of acalabrutinib tablets given with a high-fat diet compared with a fasted diet (n = 16). Another area for exploration was evaluating PK after 100 mg of acalabrutinib maleate suspension (in 15 mL of water), in the presence vs absence of rabeprazole (n = 20).