AbbVie on Thursday said it will voluntarily withdraw use of its lucrative blood cancer drug Imbruvica in two types of lymphoma after clinical studies failed to confirm benefits observed in earlier testing.
AbbVie will no longer sell the drug for mantle cell lymphoma and marginal zone lymphoma, two of the less common forms of the disease. The decision doesn’t impact any of Imbruvica’s other approvals, including its main use as an established therapy for chronic lymphocytic leukemia, an indication that led to over $3.5 billion in U.S. sales for AbbVie last year. (The drugmaker co-sells Imbruvica with Johnson & Johnson under a longstanding partnership.)
Still, AbbVie’s decision removes what was the first approval for Imbruvica. The drug initially came to market in 2013 as a treatment for mantle cell lymphoma patients who’d received at least one prior therapy. That approval and its subsequent nod in marginal zone lymphoma were “accelerated” clearances that had to be confirmed in additional testing to be upheld.
While a follow-up study called SHINE in mantle cell lymphoma met its main goal of slowing tumor progression, the tested regimen of Imbruvica and chemotherapy didn’t extend survival and was associated with more Grade 3 or 4 adverse reactions. The confirmatory study in marginal zone lymphoma, meanwhile, didn’t succeed. Detailed results from that trial will be presented at a future medical meeting, according to AbbVie.
“While we are disappointed in the outcome of the confirmatory trials for these indications, we remain confident in the benefit/risk profile of Imbruvica for patients living with multiple forms of blood cancer around the world,” said Roopal Thakkar, AbbVie’s senior vice president and chief medical officer, in a statement.
The decision makes AbbVie the latest to pull use of a drug that had previously received an accelerated approval, a trend that’s become more common as the Food and Drug Administration has increasingly cracked down on drugs that haven’t confirmed earlier testing results.
Over the last few years, for instance, large drugmakers such as Merck & Co., AstraZeneca, GSK and Roche have withdrawn indications for cancer medicines that had previously won accelerated approvals.
FDA scrutiny hasn’t been only limited to cancer medicines. On Thursday, the regulator removed an approval of the preterm birth drug Makena after finding “no justification” for keeping it on the market.
AbbVie said it “fully supports the FDA accelerated approval process” and is working with the agency to complete the withdrawals of Imbruvica.