Recent updates in hematology/ oncology

FDA has approved acalabrutinib for adults with chroniclymphocytic leukemia or small lymphocytic lymphoma as an initial or subsequent therapy. This would mark the second approval under Project Orbis.

FDA used the Real-Time Oncology Review pilot program in its review of the application for acalabrutinib, a process to streamline the submission of data before the completion of the entire drug application “Today, as part of a U.S., Australian and Canadian collaboration known as Project Orbis, the U.S. approved a new treatment option for those living with chronic lymphocytic leukemia or small lymphocytic lymphoma. The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international partners,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a press release.

The FDA based this supplemental approval of acalabrutinib on data from two randomized studies. 

The first trial, which included 535 patients with previously untreated CLL- showed longer PFS among patients assigned acalabrutinib compared with other standard treatments.

The second trial of 310 patients with CLL also showed longer PFS with acalabrutinib vs. other standard treatments.

Common adverse events associated with acalabrutinib included anemia, neutropenia, upper respiratory tract infection, thrombocytopenia headache, diarrhea and musculoskeletal pain.

For more updates on hematology or cancer, please join us at, PS: http://tiny.cc/9t8ybz

Source: Healio hemonc today