The FDA has signed off on a new tablet formulation for acalabrutinib (Calquence) for patients with CLL / SLL, according to a news release from drugmaker AstraZeneca. It is now possible to take acalabrutinib along with stomach acid-reducing agents.
The agency also approved the table for patients with relapsed or refractory mantle cell lymphoma (MCL).
Patients with CLL or SLL often experience acid reflux or peptic ulcer disease requiring treatment with acid-reducing agents such as proton pump inhibitors (PPIs), antacids, and H2-receptor antagonists (H2RAs). In its previous caplet formulation, it was not possible to use these agents because they could reduce the efficacy of acalabrutinib.
Furthermore, some patients have difficulty swallowing the capsule and were forced to take the drug in other ways, such as oral suspensions or nasogastric tubes. Such patients should find the new film-coated tablet easier to use.
The FDA approved the new tablet formulation based on results from the ELEVATE-PLUS trial published last year in the journal Blood. Investigators found no difference in efficacy for patients who received the tablet with or without a PPI. Investigators added that the tablet improves swallowing and “can be easily suspended in a small amount of water to allow dosing in patients unable to swallow tablets.”
Moreover, food had no “clinically relevant impact” on the efficacy of the acalabrutinib tablet. Investigators said the tablet is comparable to the previously approved 100 mg daily dose.
“Approval of acalabrutinibin a tablet form enables co-administration of the acalabrutinib tablet alongside a proton pump inhibitor,” Dr John C. Byrd, chair of the Department of Internal Medicine at the University of Cincinnati and a consultant with AstraZeneca, said in a news release. “This provides another option for some patients with chronic lymphocytic leukemia and relapsed/refractory mantle cell lymphoma, enabling more patients to potentially benefit from this treatment.”
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