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.
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