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AbbVie unveils Venclexta data that scored lightning-fast leukemia combination nod.

June 04, 2019 / Carly Helfand

Last month, partners AbbVie and Roche nabbed a speedy approval for Venclexta and Gazyva in chronic lymphocytic leukemia (CLL). And Tuesday, they rolled out the data that helped get them to the finish line. A phase 3 study presented at the American Society of Clinical Oncology annual meeting showed that in previously untreated patients with both CLL and other medical conditions, the combination cut the risk of disease progression or death by 65% versus Gazyva and chlorambucil, a regimen commonly used to treat that population.At the two-year mark, 88.2% of patients in the Venclexta arm hadn’t seen their disease worsen,compared with 64.1% of patients on the standard-of-care combination.Those results apparently impressed regulators, who green-lighted the combination in mid-May under the FDA’s new Real-Time Oncology Review pilot. The program allows regulators to begin going through data before a company officially submits its complete application, and it yielded a go-ahead for t...