Venclyxto combo scores European approval for previously untreated chronic lymphocytic leukaemia

Image Credit: Mary Ann Thompson

The European Commission has moved to authorise AbbVie and Roche’s B-cell lymphoma-2 (BCL-2) inhibitor Venclyxto (venetoclax) when used in combination with obinutuzumab for the treatment of chronic lymphocytic leukaemia (CLL) in previously untreated adult patients.

Phase 3 data supplied in support of the application showed that the drug combo demonstrated superior progression-free survival (PFS) compared to a regimen containing standard-of-care chemotherapy chlorambucil plus obinutuzumab; 36-month PFS estimates stood at 81.9% compared to 49.5% with chlorambucil plus obinutuzumab.

The decision follows a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in the same indication in January this year.

"CLL is the most common of the nearly 95,000 new cases of leukaemia in Europe each year, and chemotherapy is often the first line of treatment," said Dr Michael Hallek, Lead Investigator of the CLL14 study, Director of the Department of Internal Medicine and Center of Integrated Oncology at the University Hospital Cologne in Germany, and Head of the German CLL Study Group. "Having the option to utilise a first-line, chemotherapy-free treatment combination that can produce a deep response, thus allowing patients to stop treatment, will change the way we treat CLL and have a significant impact on patients."

Matt Fellows