AstraZeneca’s Calquence has been given a speedy green light in the US as a treatment for adults with mantle cell lymphoma.
Mantle cell lymphoma is a rare and fast-growing type of non-Hodgkin lymphoma, currently accounting for three to 10 percent of all non-Hodgkin lymphoma cases in the US, according to the National Cancer Institute at the National Institutes of Health.
AZ’ kinase inhibitor is approved under the FDA’s accelerated approval pathway, which allows for earlier approval of medicines that treat serious conditions and that fill an unmet medical need, and as such continued approval may be contingent upon verification of clinical benefit in confirmatory trials.
Accelerated clearance was issued on the back of data, from a 124-patients, single-arm trial showing that 81 percent of patients taking Calquence (acalabrutinib) experienced tumour shrinkage to some degree (40 percent complete response, 41 percent partial response).
On the safety side, common side effects were found to be headache; diarrhoea; bruising; fatigue and muscle pain; anaemia, platelets (thrombocytopaenia) and neutrophils in the blood, while those more serious included bleeding, infections and irregular heartbeat.
“The acalabrutinib approval represents an important development for patients currently battling mantle cell lymphoma, an aggressive type of blood cancer that is typically diagnosed at an advanced stage and associated with a high relapse rate,” said Michael Wang, professor, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, and principal investigator of the ACE-LY-004 MCL clinical trial.
“In addition to the overall response rate, the high complete response rate of 40 percent seen in this trial illustrates the potential of acalabrutinib to help patients achieve a deep response.”
“The accelerated approval of Calquence is a landmark moment for our company,” added Pascal Soriot, AZ’ chief executive. “It provides an exciting new treatment option for patients with mantle cell lymphoma and marks the first approval of a medicine that will be the cornerstone of our presence in haematology”.