FDA OKs AstraZeneca’s Calquence for lymphocytic leukemia

AstraZeneca (AZN +1.1%) says the FDA approved Calquence (acalabrutinib) as a treatment for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

AZN says the approval was based on positive results from two phase 3 clinical trials that showed Calquence in combination with obinutuzumab or as a monotherapy significantly reduced the relative risk of disease progression or death.

The U.S. approval is among the first to be granted under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among the FDA’s international partners.

https://seekingalpha.com/news/3521306-fda-oks-astrazenecas-calquence-lymphocytic-leukemia