Please login to the form below

Not currently logged in

AbbVie and Roche to launch Venclexta within a week

FDA approves first-in-class BCL-2 inhibitor to treat chronic lymphocytic leukaemia patients

The FDA has approved AbbVie and Roche's Venclexta, a first-in-class BCL-2 inhibitor that has been given the nod to treat a subgroup of chronic lymphocytic leukaemia (CLL) patients.

The US regulator cleared Venclexta (venetoclax) as a treatment for CLL patients who carry a mutation known as a 17p deletion and have been treated with at least one prior therapy after a review of just three months. AbbVie and Roche say they plan to start shipping the new product within the next week.

CLL is a slow-progressing cancer of the bone marrow and blood and is the most common leukaemia diagnosed in adults in western countries, with around 15,000 new cases a year in the US.

The 17p deletion - which results in the loss of a tumour suppressor gene - is found in around 10% of early CLL cases but upwards of 20% among patients with more advanced disease. A companion diagnostic developed by Abbott is already available to identify patients with the mutation.

The FDA approval is based on a clinical trial involving 106 previously-treated patients with 17p deletion-positive CLL who took Venclexta orally once-a-day in escalating doses. The results showed that 80% of trial participants experienced a complete or partial remission of their cancer.

Analysts have suggested that Venclexta could become a blockbuster product for Roche and AbbVie with sales in excess of $1.5bn a year, thanks in part to a price tag of around $110,000 for the first 12 months' treatment but also other potential uses in non-Hodgkin's lymphoma (NHL), acute myeloid leukaemia and multiple myeloma.

The two companies will co-market the new product in the US while AbbVie has sole marketing rights in other markets.

Venclexta will compete in the market with other new therapies for CLL, including Johnson & Johnson's first-in-class BTK inhibitor Imbruvica (ibrutinib) and Gilead Sciences' PI3 kinase inhibitor Zydelig (idelalisib), which is specifically indicated for use in 17p deletion-positive patients.

Both Imbruvica and Zydelig were approved for CLL in 2014 and have been tipped to become $1bn-plus products at peak. J&J reported $689m in Imbruvica sales in 2015, while Zydelig made $132m.

Meanwhile, Roche is already a player in the first-line CLL setting with Gazyva (obinutuzumab), which was approved in 2013.

Article by
Phil Taylor

12th April 2016

From: Regulatory



Featured jobs

Subscribe to our email news alerts


Add my company

AMICULUM® is an independent global healthcare communications, consulting and learning business with a global team of >220 healthcare communications professionals,...

Latest intelligence

Marketing to healthcare professionals – what’s the key ingredient missing from most campaigns?
What do you think is the difference between a campaign developed to win a share-of-mind with consumers and a campaign designed to gain the attention of healthcare professionals?...
What everyone forgets about good organisational change in pharma
Natasha Cowan speaks to Daphne Chung, Head of Organisational Transformation, to learn how she ensures smooth organisational change that takes all stakeholders into account....
Live from Singapore: Oncology in APAC - Evaluating the opportunity for novel therapies
Live webinar: Tuesday 11th December 2018,16:00 SGT / 17:00 JST...