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Roche keeps Venclexta train rolling with new leukaemia filing

The drug could treat AML patients who are ineligible for chemotherapy


Roche and partner AbbVie have filed their fast-growing blood cancer drug Venclexta in the US as a first-line treatment for acute myelogenous leukaemia (AML), a key new indication for the would-be blockbuster.

The filing is for use of the BCL-2 inhibitor in previously-untreated AML patients who are ineligible for intensive chemotherapy, the standard front-line treatment for what is the most common form of aggressive leukaemia in adults.

The submission is based on the results of two phase Ib/II studies that looked at the combination of Venclexta (venetoclax) and low-dose chemotherapy. Data reported at this year’s American Society of Clinical Oncology (ASCO) meeting showed overall responses rates above 80%, with complete responses seen in upwards of 60% of patients – a step up on what is seen with standard induction chemotherapy – and with responses typically lasting at least nine months.

Overall survival was around a year and a half in some cases, a big improvement as most studies in this patient group struggle to extend OS beyond 12 months.

Venclexta was first approved as a second-line therapy for chronic lymphocytic leukaemia (CLL) patients with a chromosomal abnormality known as 17p deletion in 2016 and – last month – the eligible patient population was expanded after the regulator okayed its use alongside Roche’s Rituxan (rituximab) for all relapsed/refractory CLL patients based on the MURANO trial results.

The expanded CLL indication is also under review in the EU and should help to accelerate sales of Venclexta, which according to EvaluatePharma could become a near-$2.5bn product by 2024, providing it can also pick up approvals in AML and other indications like multiple myeloma.

“Venclexta is really turning into an important medicine,” said Roche’s head of pharma Daniel O’Day earlier this year after the company reported a 52% increase in first quarter sales of the drug to $59m. Roche's Genentech unit is collaborating with the company on Venclexta's development and the two firms co-market the drug in the US, with AbbVie selling it on its own elsewhere.

“Nearly 20,000 people will be diagnosed with AML in the US this year, and many of them are not eligible to receive standard intensive chemotherapy,” commented Roche’s chief medical officer Sandra Horning.

“AML is an aggressive disease with the lowest survival rate of all leukaemias, and we look forward to working closely with the FDA to bring this potential option to patients with this very difficult-to-treat blood cancer as soon as possible.”

Article by
Phil Taylor

12th July 2018

From: Regulatory



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