AstraZeneca announced that the U.S. FDA has approved Calquence for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma.
The approval for the BTK inhibitorwas granted under the newly established Project Orbis program, which provides a framework for concurrent submission and review of oncology medicines among the FDA's international partners. Consequently, regulators in Canada and Australia also gave Calquence the green light.
In the U.S., the Calquence was previously was granted approval in October 2017 for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. The newest approval means the treatment will now compete with Johnson & Johnson and AbbVie’s Imbruvica, first approved in 2016, in the previously untreated chronic lymphocytic leukemia space.
Read the press release