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EU grants approval for Venclyxto/Gazyvaro combo in CLL

Chemotherapy-free option for previously-untreated patients


The European Commission has approved a combination of Roche’s Venclyxto and Gazyvaro as a chemotherapy-free therapy for previously-untreated chronic lymphocytic leukaemia (CLL).

Venclyxto (venetoclax) – known as Venclexta in the US – was co-developed by AbbVie and Roche and the combination with Gazyva (obinutuzumab) in frontline treatment of CLL could see its use expanded.

It’s a fillip for both AbbVie and Roche after venetoclax missed the mark in a confirmatory trial in acute myeloid leukaemia (AML) earlier this month, placing its conditional approval in this indication in jeopardy.

That was a rare misfire for a drug that has been in the ascendency of late, with AbbVie reporting last month that sales of the drug more than doubled to $792m last year and are expected to top $1.3bn in 2020. AbbVie sells the drug on its own outside the US, with Roche sharing commercialisation in the US market.

The latest green light is based on the CLL14 trial, which also resulted in FDA approval for the pairing last year. In the study, the combination led to a 65% reduction in the risk of disease progression or death compared with Gazyvaro plus chlorambucil in this first-line treatment setting, with a tolerable safety profile.

“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 lead study investigator Michael Hallek of University Hospital Cologne in Germany.

“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,” he added.

It remains to be seen whether the draw of chemo-free therapy will be enough to offset the increased cost of the two drugs, and the availability of biosimilar versions of rituximab – Gazyvaro’s precursor – could also impact take-up.

It also has to contend with the combination of AbbVie’s Imbruvica (ibrutinib) plus Gazyvaro, which became the first chemo-free option for first-line CLL therapy last year.

The combination will however provide an immediate new option for patients who are ineligible for chemotherapy.

Roche is emphasising that the Venclyxto/Gazyvaro combination has a fixed therapy duration of 12 months, which means that patients can have an end date for treatment.

Article by
Phil Taylor

13th March 2020

From: Regulatory



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