Calquence receives full FDA approval for first-line treatment of Mantle Cell Lymphoma

USA—AstraZeneca, a global biotech leader, 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 treating mantle cell lymphoma (MCL).

 This approval marks a significant milestone, as Calquence is now the first BTK inhibitor approved for adults with untreated MCL who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).

The FDA approved Calquence in combination with bendamustine and rituximab as a treatment for adult patients with previously untreated MCL, a rare and aggressive form of non-Hodgkin lymphoma.

MCL is typically diagnosed at later stages, and it involves the malignant transformation of B lymphocytes in the lymph node mantle zone.

Calquence’s approval expands its use in combination with chemoimmunotherapy, offering a new treatment option for patients who are unsuitable for HSCT.

This approval also converts Calquence’s previous accelerated approval, granted in 2017 for adult MCL patients treated with at least one prior therapy, to a full approval.

The decision was based on data from the Phase III ECHO trial (NCT02972840), which was presented at the European Hematology Association 2024 Congress.

The trial enrolled 598 patients aged 65 or older with untreated MCL who were unsuitable for HSCT.

Participants were randomized to receive either Calquence combined with chemotherapy (bendamustine and Rituxan, a Biogen and Genentech product) or a placebo plus the same chemotherapy regimen.

Results from the trial showed that the median progression-free survival (PFS) was 66.4 months for patients receiving Calquence, compared to 49.6 months for those on the placebo. This represents a 27% improvement in PFS, a key indicator of treatment efficacy.

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Hematology Business Unit, commented on the approval, highlighting that Calquence offers a vital new treatment option for MCL patients in the US.

He emphasized that the treatment has proven to provide nearly one and a half years of additional time without disease progression.

Calquence, a next-generation selective BTK inhibitor, works by binding covalently to the BTK active site, inhibiting its enzymatic activity, and thereby suppressing the proliferation and survival of malignant B cells.

With this approval, AstraZeneca’s Calquence holds a significant first-mover advantage in the treatment-naive MCL market, positioning it ahead of competitors like BeiGene’s Brukinsa (zanubrutinib), Eli Lilly’s Jaypirca (pirtobrutinib), and InnoCare’s Inokai (orelabrutinib), all of which are still in late-stage clinical trials for this indication.

The approval also marks a major setback for AbbVie and Johnson & Johnson’s Imbruvica (ibrutinib), which was previously expected to dominate the market.

Imbruvica lost its accelerated approval in 2023 after the Phase III SHINE trial revealed no overall survival benefit and an increased mortality risk in treated patients.

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