AbbVie gets a green light to resume recruiting patients for one myeloma study — but Venclexta remains under a cloud
Three months after regulators at the FDA forced AbbVie to halt enrolling patients in its trials of a combination using Venclexta (venetoclax) to treat drug-resistant cases of multiple myeloma, the agency has green-lighted the resumption of one of those studies, while keeping the rest on the sidelines.
The CANOVA (M13-494) study can now get back in business recruiting patients to test the drug for a population that shares a particular genetic biomarker. To get that permission, AbbVie — which is partnered with Roche on this program — was forced to revise the protocol, making unspecified changes involving risk mitigation measures, protocol-specified guidelines and an updated futility criteria.
The rest of the myeloma studies, though, will continue without new patients for now as the FDA sorts out why researchers spotted an imbalance in the death rate between the drug arm and the control group — venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone.
The continued halt on recruitment will likely put a crimp in their plans to hit $3 billion in peak sales for the drug, which was initially limited to patients with a 17p deletion. Last summer they got an approval to use the drug with Rituxan for relapsed CLL, an add-on that Leerink’s Geoffrey Porges estimated could be worth $690 million this year alone.
“We are pleased to move forward with the CANOVA study which, with the t(11;14) biomarker test, can help identify patients who may respond better to treatment and add clarity for physicians when choosing a therapy, if approved,” said Mohamed Zaki, the global head of hematology development for AbbVie.
Social image: AbbVie