Companies: AbbVie, Johnson & Johnson
Used for: Mantle cell lymphoma, chronic lymphocytic leukemia, Waldenstrom’s macroglobulinemia, marginal zone lymphoma, chronic graft vs. host disease
2019 sales: $7.24 billion
AbbVie and Johnson & Johnson's Imbruvica has emerged as the top dog in rare blood cancers despite a rush of challengers piling in—a nice recipe for growing sales. But in its most profitable indication, chronic lymphocytic leukemia, that competition is about to get stiffer with a challenger's recent approval, and another possibly on the way.
AbbVie and J&J's Imbruvica could add $990 million in sales to its 2019 total of $7.24 billion, according to Evaluate Pharma. That would bring Imbruvica's sales this year up to $8.23 billion.
Imbruvica, a longtime powerhouse in blood cancer, scored a combination FDA nod alongside Roche's Gazyva last January as the first non-chemo treatment for previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma.
The FDA based its green light 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.
In addition to providing a chemo-free option for patients, the approval allowed AbbVie and J&J to push further into a market they’re already leading after snatching the majority of market share in late 2018. But competitors are knocking on the door.
In November, the FDA approved AstraZeneca's Calquence in newly diagnosed CLL or small lymphocytic lymphoma. The agency based the decision on data from two phase 3 trials showing Calquence could top standard therapies at staving off cancer progression. The FDA also examined AZ's application under its real-time oncology review program, which allows the agency to begin sifting through data before a company submits its full application.
And then there's BeiGene's Brukinsa, which hasn't yet entered the CLL arena, though it's preparing to.
In a phase 3 study last year, BeiGene’s newcomer failed to significantly outdo Imbruvica at provoking complete responses—erasing signs of disease activity completely—or so-called “very good” partial responses in patients with Waldenstrom macroglobulinemia.
While the Waldenstrom population is a relatively small one, industry watchers were using the trial to benchmark Brukinsa’s prospects against Imbruvica in other cancers—namely CLL, where analysts are already forecasting a showdown in previously untreated patients—and they liked what they saw. For now, though, Brukinsa bears just one approval, in mantle cell lymphoma.