FDA Grants Second Approval in Collaboration With TGA and Health Canada

The FDA approved AstraZeneca’s Calquence (acalabrutinib) to treat adults with chronic lmphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), marking the agency’s second approval in collaboration with Australia and Canada under Project Orbis.

The approval was based on two randomized clinical trials that compared Calquence to standard treatments. Both trials showed that  those receiving Calquence had a longer progression-free survival.

The FDA previously granted accelerated approval under Project Orbis for Eisai’s Lenvima (lenvatinib) in combination with Merck’s Keytruda (pembrolizumab) for certain patients with advanced endometrial cancer.