AstraZeneca has announced the US Food and Drug Administration (FDA) Priority Review for Calquence (acalabrutinib) to treat adults with previously untreated mantle cell lymphoma (MCL).
The US health agency accepted the British drugmaker’s supplemental New Drug Application (sNDA) for Calquence, with a Prescription Drug User Fee Act date set in Q1 2025.
Calquence is an advanced, highly selective BTK inhibitor that binds covalently to BTK to inhibit its activity and is currently used to treat certain types of blood cancers.
The drug is already approved in the US to treat chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL), and MCL in patients who have received at least one prior therapy.
MCL is a rare and aggressive form of non-Hodgkin lymphoma (NHL) caused when the B-lymphocytes mutate into malignant cells within the mantle zone of the lymph node.
The US FDA reviewed the company’s sNDA under its Project Orbis initiative, which enables concurrent submission and review of oncology drugs among global partners.
AstraZeneca oncology R&D executive vice president Susan Galbraith said: “Today’s Priority Review acceptance reinforces the potential of Calquence to transform outcomes in untreated mantle cell lymphoma.
“Data from the ECHO trial showed Calquence plus chemoimmunotherapy significantly delayed disease progression and showed a trend to improved survival in patients with this currently incurable blood cancer.”
AstraZeneca’s sNDA submission is based on results from ECHO, a randomised, double-blind, placebo-controlled, multi-centre Phase 3 study.
The study evaluated Calquence plus bendamustine and rituximab compared to SoC chemoimmunotherapy (bendamustine and rituximab) in adults with previously untreated MCL.
In the Phase 3 study, Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care (SoC) chemoimmunotherapy.
The addition of Calquence to SoC provided almost 1.5 years of additional median progression-free survival (mPFS) of 66.4 months, compared to 49.6 months with SoC.
Also, the Calquence combination showed a favourable trend in the overall survival (OS), compared to SoC chemoimmunotherapy, which was sustained over time.
Calquence showed safety and tolerability that were consistent with its known safety profile, with no new safety signals identified, said the British pharmaceutical company.
