AbbVie gets positive CHMP Opinion for VENCLYXTO for Leukemia patients

New Delhi: AbbVie , a research-based global biopharmaceutical company, announced recently that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for VENCLYXTO (venetoclax) in combination with obinutuzumab for the treatment of patients with chronic lymphocytic leukaemia (CLL) who were previously untreated.

The positive CHMP opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which is expected to deliver its final decision in the first half of 2020.

"The positive CHMP opinion for this new indication in chronic lymphocytic leukaemia is an important step forward for patients and underscores the growing utility of VENCLYXTO in treating this common blood cancer," said Neil Gallagher, M.D., Ph.D., chief medical officer and vice president of development. "If approved by the EC, the venetoclax and obinutuzumab combination would be the first chemotherapy-free option for treatment-naïve patients with chronic lymphocytic leukaemia where dosing can be completed in one year."

The CHMP positive opinion is based on results from the Phase 3 CLL14 clinical trial, which evaluated the efficacy and safety of VENCLYXTO in combination with obinutuzumab compared with chlorambucil in combination with obinutuzumab. The primary endpoint was progression-free survival (PFS; the time on treatment without disease progression or death) as assessed by an investigator. At the time of analysis, investigator-assessed results demonstrated that patients treated with VENCLYXTO plus obinutuzumab achieved superior PFS compared to patients treated with obinutuzumab plus chlorambucil. Adverse events were consistent with the known safety profiles of venetoclax and obinutuzumab alone. At least one AE of any grade occurred in 94.3 per cent of patients in the venetoclax combination arm, with the most common Grade 3/4 AEs in patients being febrile neutropenia and infections. Tumour lysis syndrome (TLS) was reported in three patients in the venetoclax plus obinutuzumab group (all during treatment with obinutuzumab and before venetoclax).1 Results from the CLL14 trial were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine.

"Chemotherapy has historically been the first treatment for patients with chronic lymphocytic leukaemia. If the venetoclax plus obinutuzumab combination is approved in the EU, previously-untreated patients will, for the first time, have a chemotherapy-free, fixed-duration treatment option," said Michael Hallek, M.D., lead investigator of the CLL14 study, Director of the Department of Internal Medicine and Center of Integrated Oncology Cologne-Bonn at the University Hospital Cologne in Germany, and Head of the German CLL Study Group. "The early use of venetoclax plus obinutuzumab combination has the potential to change the treatment paradigm for chronic lymphocytic leukaemia as it has been demonstrated to improve outcomes, allowing patients to live longer without disease progression."

In 2018, the EC approved VENCLYXTO plus rituximab for the treatment of patients with relapsed or refractory (R/R) CLL. VENCLYXTO monotherapy was previously approved in the EU for R/R CLL in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.

VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

VENCLYXTO is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other cancerous tumors, BCL-2 builds up and prevents cancer cells from undergoing their natural death or self-destruction process, which is called apoptosis. VENCLYXTO targets the BCL-2 protein and works to restore the process of apoptosis.

VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several bloods and other cancers.

VENCLYXTO is approved in more than 50 countries, including the U.S. AbbVie and Roche are currently working with regulatory agencies around the world to bring this medicine to additional eligible patients in need.

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