FDA Approves AstraZeneca's Calquence for Untreated Mantle Cell Lymphoma

AstraZeneca's Calquence (acalabrutinib) has received approval from the US Food and Drug Administration (FDA) for a combination treatment aimed at tackling mantle cell lymphoma (MCL). This treatment is designated for adults who have not previously been treated and are not suitable candidates for autologous haematopoietic stem cell transplantation. The combination includes Calquence taken with the standard chemoimmunotherapy regimen of bendamustine and rituximab.

MCL is a particularly aggressive and rare subtype of non-Hodgkin lymphoma, affecting over 27,500 people worldwide. It is generally diagnosed at a later stage, making effective treatment options crucial. Calquence, an oral medication developed by AstraZeneca, functions by inhibiting Bruton’s tyrosine kinase protein, which is responsible for the proliferation of malignant B cells.

Initially, Calquence was granted accelerated approval by the FDA in 2017 for treating adults with MCL who had undergone at least one prior therapy. The recent FDA decision has now shifted this to full approval. This new development follows encouraging findings from the ECHO trial, a late-stage study, which demonstrated that Calquence, in combination with bendamustine and rituximab, decreased the risk of disease progression or death by 27% compared to the typical chemoimmunotherapy.

AstraZeneca reported that despite the challenges posed by the COVID-19 pandemic, patient enrollment in the ECHO trial continued. When accounting for deaths linked to the pandemic, the Calquence combination showed a 36% reduction in disease progression or death risk. Dave Fredrickson, executive vice-president of the oncology haematology business unit at AstraZeneca, emphasized the significance of this approval. He noted that Calquence offers MCL patients in the US a vital new treatment option, extending the period without disease progression by nearly one and a half years. This approval underscores Calquence’s potential as a foundational therapy for various blood cancers.

In addition to its recent approval for MCL, Calquence holds authorizations for treating certain individuals with chronic lymphocytic leukaemia and small lymphocytic lymphoma. The drug is also undergoing evaluation both as a standalone treatment and in combination with conventional chemoimmunotherapy for various B-cell blood cancers, including diffuse large B-cell lymphoma.

AstraZeneca has indicated that regulatory applications based on the ECHO trial outcomes are currently under consideration in the European Union and other international markets. The approval marks a significant milestone in providing an effective treatment alternative for those living with MCL, reinforcing AstraZeneca’s commitment to developing Calquence as a versatile therapy across multiple blood cancer types.