CHMP recommends Imbruvica for CLL and MCL - Pharmacyclics

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the granting of full marketing approval for Imbruvica (ibrutinib), from Pharmacyclics, for the treatment of adult patients with relapsed or refractory Mantle Cell Lymphoma (MCL), or adult patients with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. The positive opinion was based on data from the Phase II study (PCYC-1104) in MCL, and a Phase III RESONATE study (PCYC-1112-CA) and a Phase II study (PCYC-1102) in CLL. A final decision on IMBRUVICA is anticipated later this year. In addition to European markets, a worldwide regulatory filing program for ibrutinib currently is underway. It received accelerated approval from the FDA for two indications based on overall response rate: for the treatment of patients with MCL and CLL who have received at least one prior therapy.