AbbVie’s Venclyxto pins down CHMP approval for treatment-naive chronic lymphocytic leukaemia
pharmafile | February 3, 2020 | News story | Sales and Marketing | AbbVie, CHMP, EMA, Venclyxto, pharma
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has awarded recommendation to AbbVie’s Venclyxto (venetoclax), it has emerged, in the treatment of previously untreated chronic lymphocytic leukaemia (CLL) when combined with obinutuzumab.
Phase 3 data submitted in support of the application showed that Venclyxto displayed “superior” benefit in progression-free survival compared to the standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil, meeting the study’s primary endpoint.
It was also found that 94.3% of patients receiving Venclyxto experienced an adverse event of any grade, while three patients were affected by tumour lysis syndrome; the company said that the drug’s safety and efficacy profile was in line with previous findings.
“The positive CHMP opinion for this new indication in chronic lymphocytic leukemia is an important step forward for patients and underscores the growing utility of Venclyxto in treating this common blood cancer,” said Dr Neil Gallagher, 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.”
A final authorisation decision is expected from the European Commission in the first half of this year.
“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 Dr Michael Hallek, lead investigator of the study, Director of the Department of Internal Medicine and Center of Integrated Oncology Cologne-Bonn at the University Hospital Cologne in Germany. “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.”
Matt Fellows
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