Calquence is forecast to generate up to $4.7bn in sales by 2030, as per GlobalData intelligence. Credit: Nadezhda Fedrunova via Getty Images.

AstraZeneca has received approval from the US Food and Drug Administration (FDA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib), for first-line use in mantle cell lymphoma (MCL).

This approval makes Calquence the first BTK inhibitor available for adults with untreated MCL who are unsuitable for autologous haematopoietic stem cell transplantation (HSCT) and allows its use in combination with chemoimmunotherapy.

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The FDA granted approval based on data from the Phase III ECHO trial (NCT02972840). The randomised, double-blind, placebo-controlled study enrolled 598 patients aged 65 or older with untreated MCL who were unsuitable for HSCT. Patients were randomised to receive Calquence with chemotherapy bendamustine and Biogen and Genentech’s Rituxan (rituximab) or placebo plus bendamustine and Rituxan.

Efficacy was measured by progression-free survival (PFS) and evaluated by an independent review committee. The median PFS was 66.4 months in the Calquence plus BR arm, compared to 49.6 months in the placebo plus bendamustine and Rituxan arm. The trial demonstrated a 27% improvement in PFS for Calquence over placebo.

MCL is a rare and aggressive subtype of non-Hodgkin lymphoma, often diagnosed in later stages and characterised by the malignant transformation of B lymphocytes in the lymph node mantle zone. Calquence, a next-generation selective and irreversible BTK inhibitor, binds covalently to the BTK active site to inhibit enzymatic activity, suppressing the proliferation and survival of malignant B cells.

AstraZeneca’s Calquence now holds a first-mover advantage in the treatment-naive MCL market, outpacing competitors such as BeiGene’s Brukinsa (zanubrutinib), Eli Lilly’s Jaypirca (pirtobrutinib), InnoCare’s Inokai (orelabrutinib), all of which remain in late-stage clinical trials for this indication. AbbVie and Johnson & Johnson’s (J&J’s) Imbruvica (ibrutinib) was previously positioned to lead the market but lost its accelerated approval in 2023 after the Phase III SHINE trial (NCT01776840) showed no overall survival benefit and a 7% increase in mortality risk for Imbruvica-treated patients.

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GlobalData projects that Calquence could generate up to $4.7bn in sales by 2030. With this FDA approval, AstraZeneca is poised to capitalise on its lead in the competitive BTK inhibitor market.

GlobalData is the parent company of Pharmaceutical Technology.