AstraZeneca’s (AZ) Calquence (acalabrutinib) has been approved by the US Food and Drug Administration (FDA) as part of a combination treatment for mantle cell lymphoma (MCL).
The drug has been authorised for use alongside standard-of-care chemoimmunotherapy, bendamustine and rituximab, in previously untreated adults who are ineligible for autologous haematopoietic stem cell transplantation.
Estimated to affect more than 27,500 people globally, MCL is a rare and typically aggressive form of non-Hodgkin lymphoma that is often diagnosed as a late-stage disease.
Taken orally, AZ’s Calquence is designed to inhibit the activity of the Bruton’s tyrosine kinase protein that leads to the growth of abnormal cancerous B cells.
The drug was approved under the FDA’s accelerated approvals pathway in 2017 to treat adults with MCL who have received at least one prior therapy, with the US regulator’s latest decision now converting this to full approval.
The new authorisation is based on positive results from the late-stage ECHO trial, in which the Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to chemoimmunotherapy.
AZ added that patients were enrolled to the study throughout the COVID-19 pandemic and, after censoring for deaths related to the virus, the Calquence combination demonstrated a 36% reduction in the risk of disease progression or death.
Dave Fredrickson, executive vice-president, oncology haematology business unit, AZ, said: “With [this] approval, Calquence provides a critical new treatment option to MCL patients in the US, with Calquence proven to deliver nearly one and a half years of additional time without disease progression.
“This approval brings a new and effective treatment option to those living with this disease and further reinforces our belief in Calquence as a backbone therapy across multiple blood cancers.”
Regulatory applications are under review in the EU, and other countries based on the ECHO results, AZ said.
Beyond, Calquence holds authorisations to treat certain patients with chronic lymphocytic leukaemia and small lymphocytic lymphoma.
The drug is also currently being evaluated as a single treatment and in combination with standard-of-care chemoimmunotherapy for patients with multiple B-cell blood cancers, including diffuse large B-cell lymphoma.