FDA approves AstraZeneca’s Calquence in chronic lymphoma
pharmafile | November 25, 2019 | News story | Sales and Marketing | Astrazenaca, Calquence, FDA, Health Canada, leukaemia, oncology
The FDA has approved AstraZeneca’s BTK inhibitor Calquence (acalabrutinib) in the treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
The US approval granted under the FDA’S Real-Time Oncology Review was one of the first to be authorised under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among international partners. The FDA also collaborated with the Australian Therapeutic Goods Administration and Health Canada on the review of Calquence.
The approval is based on two Phase 3 trials of the therapy: ELEVATE-TN in patients with previously untreated CLL and ASCEND in patients with relapsed and refractory CLL. Interim data showed that Calquence in combination with Gazyvaro as monotherapy significantly reduced the relative risk of disease progression or death, versus the comparator arms in both first-line and relapsed or refractory CLL.
Dave Fredickson, Executive Vice President, Oncology Business Unit at AstraZeneca, said that the approval of Calquence offers a ‘‘new hope’’ for patients with one of the most common types of adult leukaemia, as well as ‘‘outstanding efficacy and a favourable tolerability profile’’.
Dr Jeff Sherman, Director of Research at Willamette Valley Cancer Institute, Medical Director of Hematology Research for the US Oncology Network and a lead author of the ELEVATE-TN trial, said that the trials comparing Calquence to other treatments “demonstrated a clinically meaningful improvement in progression-free survival in patients across multiple settings, while maintaining is favourable tolerability and safety profile.’’
The FDA approval of Calquence followings its decision to authorise Beigene’s BTK inhibitor Brukinsa (zanubrutinib) to treat patients with relapsed refractory MCL who have received at least one prior therapy earlier this November.
Conor Kavanagh
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