Johnson & Johnson is a step closer to realizing its vision of creating an all-oral, once daily, fixed-duration treatment regimen for chronic lymphocytic leukemia (CLL) patients. The Big Pharma’s strategy advanced last week when the European Medicines Agency’s drug review committee backed the candidate.
Last month, a paper published in NEJM Evidence described a phase 3 clinical trial of Imbruvica, which is sold by J&J in the EU, in combination with venetoclax. AbbVie sells venetoclax in the EU as Venclyxto. The study found the combination achieved better progression-free survival and deeper, more sustained responses in CLL patients than a cocktail of chlorambucil and obinutuzumab.
Weeks later, J&J has received regulatory support for the Imbruvica-venetoclax combination. The EMA’s Committee for Medicinal Products for Human Use recommended the combination for approval in adults with previously untreated CLL, leaving J&J just needing the green light from the European Commission.
“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,” Edmond Chan, EMEA therapeutic area lead, hematology, at J&J’s Janssen-Cilag, said in a statement.
J&J explored the combination in light of the potentially complementary mechanisms of action of the two molecules. Ibrutinib, the active ingredient in Imbruvica, is a Bruton tyrosine kinase inhibitor that is the recommended first-line treatment for CLL but only rarely causes deep remissions and is vulnerable to the emergence of resistance mutations.
Venetoclax is an oral inhibitor of B-cell lymphoma-2. J&J speculated that the molecules could collectively eliminate dividing and resting leukemic subpopulations. With the phase 3 trial offering support for that hypothesis, J&J is now closing in on approval in the EU.