The US Food and Drug Administration (FDA) has approved Calquence for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
The action is based on positive results from the interim analyses of two Phase III clinical trials. Together, the trials showed that Calquence in combination with obinutuzumab or by itself significantly reduced the risk of disease progression or death.
Dave Fredrickson, executive vice president, Oncology Business Unit said: “With over 20,000 new cases anticipated this year in the US alone, today’s approval of Calquence provides new hope for patients with one of the most common types of adult leukemia, offering outstanding efficacy and a favorable tolerability profile. The chronic lymphocytic leukemia patient population is known to face multiple comorbidities, and tolerability is a critical factor in their treatment.”
Detailed results of the trials will be released at an upcoming conference.
The US approval is among the first to be granted under Project Orbis, an initiative of the US FDA Oncology Center of Excellence, which provides a framework for concurrent submission and review of oncology medicines among international partners. The FDA, the Australian Therapeutic Goods Administration, and Health Canada collaborated on the review.
As part of an extensive clinical development program, AstraZeneca and Acerta Pharma are currently evaluating Calquence in 23 company-sponsored clinical trials.
Chronic lymphocytic leukemia (CLL) is one of the most common types of leukemia in adults, with an estimated 105,000 new cases globally each year and 20,720 new cases in the US in 2019, and the number of people living with CLL is expected to grow with improved treatment as patients live longer with the disease.
In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections.
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