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-oncogene protein c-bcl-2 inhibitor from AbbVie’s Genentech division.
“With this innovative treatment regimen, healthcare professionals would have the flexibility to use ibrutinib either in a fixed-duration combination or as a continuous therapy, helping them to better tailor frontline CLL therapy based on patients’ individual needs,” said Dr. Edmond Chan, EMEA therapeutic area lead hematology at Janssen-Cilag Ltd.
“This recommendation brings us one step closer to European Commission (EC) approval and to providing patients with an all-oral, once-daily, fixed-duration regimen, which until this point has not been available with the BTK inhibitor class of treatments.”
Imbruvica generated $9.8 billion in sales last year. It drove $9.4 billion in revenue in 2020.
JNJ shares ticked up 1.46% to $182.29.
In March, Janssen asked EMA to approve Imbruvica (ibrutinib) with bendamustine and rituximab (BR) for adults with previously untreated mantle cell lymphoma (MCL).