8. Imbruvica


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. 

RELATED: Johnson & Johnson, AbbVie shore up Imbruvica's CLL lead with Gazyva combo win

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. 

RELATED: BeiGene's Brukinsa misses in Imbruvica head-to-head, but analysts still chalk up a win

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. 

8. Imbruvica