Janssen (NYSE:JNJ) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Imbruvica (ibrutinib) with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukemia (CLL).
In the EU, the drug is also indicated for certain patients with mantle cell lymphoma, previously treated chronic lymphocytic leukemia and Waldenström’s macroglobulinemia, also known as lymphoplasmacytic lymphoma.
CHMP’s recent positive opinion was based on the Phase 3 GLOW and Phase 2 CAPTIVATE studies.
Janssen noted in a press release that if the new indication is approved, Imbruvica will be the first oral, once-daily, fixed-duration, combination regimen for first-line treatment of CLL.
Janssen developed the drug with Pharmacyclics LLC, an AbbVie company.
Imbruvica is a Bruton’s tyrosine kinase inhibitor. Venetoclax is an apoptosis stimulant and proto…