Add another indication for Imbruvica in chronic lymphocytic leukemia to the list.
On Monday, partners AbbVie and Johnson & Johnson said the standout drug had picked up another FDA approval in the disease, this time in combination with Roche’s Gazyva. The agency greenlighted the pair for previously untreated CLL or small lymphocytic lymphoma (SLL).
The newest go-ahead is the third for Imbruvica in the first-line CLL population, where it’s already cleared both as a single agent and as part of a cocktail that also includes bendamustine and Roche’s Rituxan.
Regulators based their decision on data from the phase 3 Illuminate study, which showed that the Imbruvica-Gazyva combo could slash the risk of disease progression or death by 77% compared with Gazyva and chlorambucil.
That trial was “really the first study to prospectively evaluate a chemo-free regimen versus a chemo combination in patients with high-risk disease,” and those high-risk patients showed “a remarkable benefit,” Danelle James, M.D., head of clinical science at AbbVie’s Pharmacyclics, said in an interview at December’s American Society of Hematology annual meeting.
In addition to providing a chemo-free option for patients, the new approval will allow AbbVie and J&J to push further into a market they’re already leading. On last week’s fourth-quarter conference call, J&J executives said that based on third-quarter data, the drug had stolen the crown for U.S. new patient and total patient share in CLL.
And it was no accident. The drug has now scored four phase 3 CLL wins in studies that were “really made complementary” to “cover the entire spectrum of CLL,” James said, adding that in “the front-line setting, it’s almost like no patient left behind.”
Imbruvica’s CLL promise was a large part of what convinced AbbVie to shell out a whopping $21 billion for Pharmacyclics back in 2015. For 2019, the Illinois company expects total sales of the drug to reach $4.4 billion, up from $3.6 billion last year.