The US Food and Drug Administration (FDA) has taken a significant step forward in the fight against mantle cell lymphoma (MCL) by accepting and granting Priority Review to AstraZeneca Plc’s supplemental marketing application for Calquence (acalabrutinib). This approval pathway is reserved for drugs that have the potential to offer significant improvements in the treatment of serious conditions, underscoring the promise of Calquence for patients with MCL.
The FDA’s decision is based on the compelling results of the ECHO Phase III trial, which demonstrated the efficacy of Calquence in treating previously untreated MCL. The trial, which was conducted during the COVID-19 pandemic, showed that Calquence, when combined with bendamustine and rituximab, reduced the risk of disease progression or death by 27% compared to standard-of-care (SoC) chemotherapy. This translates to a significant increase in progression-free survival (mPFS) for patients receiving the Calquence combination, with a median mPFS of 66.4 months compared to 49.6 months for those receiving SoC. The trial also showed a favorable trend for overall survival (OS) in the Calquence arm, although the OS data were not mature at the time of this analysis.
Mantle cell lymphoma (MCL) is a rare and aggressive type of non-Hodgkin lymphoma that affects B-lymphocytes, a type of white blood cell crucial for the immune system. The disease is characterized by the malignant transformation of B-lymphocytes within the mantle zone, a region of the lymph node. It is estimated that over 27,500 people worldwide are living with MCL.
The FDA is anticipated to make its regulatory decision on Calquence’s application during the first quarter of 2025. This news is a positive development for patients with MCL, offering a potential new treatment option with the potential for improved outcomes. The Priority Review designation, along with the encouraging results from the ECHO trial, highlights the potential of Calquence as a significant advancement in the treatment of this rare and aggressive cancer.
