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AbbVie/Roche gain FDA approval for blockbuster treatment

Published on 11/06/18 at 01:13pm

AbbVie and Roche have a chalked up a major success, after the FDA gave its approval for Venclexta, in combination with rituximab, for the treatment of patients with chronic lymphocytic leukaemia (CLL).

This regimen will be available on a second-line basis and will be the first oral-based, chemotherapy-free treatment for CLL.

The treatment is tipped to become a blockbuster earner for the companies, with peak sales estimates of between $2.5 billion to $3 billion.

In trials, the combination therapy achieved an overall response rate of 92% and reduced the risk of disease progression or death by 81%.

“Venclexta now gives indicated patients a new opportunity to significantly reduce the risk of their disease progressing, compared to a current standard of care. This combination provides previously treated CLL or SLL patients with a chemotherapy-free, fixed duration treatment allowing patients the ability to stop treatment after approximately two years,” said Michael Severino, Executive Vice President, R&D and Chief Scientific Officer, AbbVie. “This is an important step for patients and we look forward to continuing to provide new treatment options for people living with difficult-to-treat blood cancers.”

It looks likely that approval in the European markets should not be far behind, with a submission already underway with the EMA.

Beyond CLL, the companies are also examining using the treatment with other cancer types. In particular, the companies announced that they were examining the therapy as a treatment for people with untreated acute myeloid leukaemia who are ineligible for chemotherapy.

Ben Hargreaves

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