USFDA approves AstraZeneca’s new tablet formulation of Calquence

According to the drug maker, the approval by the US Food and Drug Administration (FDA) was based on results from the ELEVATE-PLUS trials presented during the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition in December 2021.

USFDA approves AstraZeneca’s new tablet formulation of Calquence
82.4 percent of Japan’s population is fully vaccinated. (File)

AstraZeneca on Friday announced that it’s new tablet formulation of Calquence has been approved in the United States for all current indications, including adult patients with chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL) and for patients with relapsed or refractory mantle cell lymphoma (MCL), which is approved under accelerated approval based on overall response rate.

According to the drug maker, the approval by the US Food and Drug Administration (FDA) was based on results from the ELEVATE-PLUS trials presented during the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition in December 2021.

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In the trials, results showed the Calquence capsule and tablet formulations are bioequivalent, indicating the same efficacy and safety profile can be expected with the same dosing strength and schedule. The tablet can be taken with gastric acid-reducing agents, including proton pump inhibitors (PPIs), antacids, and H2-receptor antagonists (H2RAs). The majority of observed adverse events (AEs) in these studies were mild with no new safety concerns identified, the company claims.

“Patients with blood cancers like chronic lymphocytic leukaemia 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 leukaemia 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 statement on Friday.

The company stated that Calquence is also approved as a capsule formulation for the same indications as the tablet in the US and in many other countries worldwide.

“Today’s approval of the new Calquence tablet formulation will offer physicians and patients increased flexibility when devising treatment plans for chronic lymphocytic leukaemia and mantle cell lymphoma. This new option is a result of our focus on understanding the wants and needs of this community and providing patient-focused solutions for their treatment,” Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, stated on Friday.

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Calquence is available for prescribing in capsule and tablet formulations in the US. Calquence tablets and capsules are approved in the US for the treatment of CLL and SLL, and for the treatment of adult patients with MCL who have received at least one prior therapy. Capsules have restrictions in relation to use with a gastric acid-reducing agents. The tablets are not licensed in the European Union.

Calquence capsules are approved for CLL in the EU and many other countries worldwide and approved in Japan for relapsed or refractory CLL and SLL. Meanwhile, a phase I trial is currently underway in Japan for the treatment of front-line CLL. Additionally, in the US and several other countries, Calquence capsules are also approved for the treatment of adult patients with MCL who have received at least one prior therapy.

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