With AstraZeneca on its heels, J&J, AbbVie's Imbruvica speeds toward new nod in Waldenström's

Imbruvica
Adding Imbruvica to Roche's Rituxan improved outcomes for Waldenström's patients across all lines of therapy. (AbbVie)

Johnson & Johnson and AbbVie’s Imbruvica is the only treatment approved for patients with the rare blood cancer Waldenström's macroglobulinemia. But before competition arrives from AstraZeneca, the companies are pushing to further widen its market.

The FDA granted a speedy review to a new Imbruvica use alongside Roche’s Rituxan, shortening the drug’s trip to the regulatory finish line. Right now, Imbruvica is approved solo for patients with Waldenström's, a rare type of non-Hodgkin's lymphoma that affects about 2,800 new U.S. patients each year.

RELATED: Just where does AbbVie expect to find $7B in Imbruvica sales?

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The agency based its decision on results from the Innovate study, rolled out at the American Society of Clinical Oncology annual meeting earlier this month, which showed that adding Imbruvica to Rituxan could stave off the disease better than Rituxan alone. The pairing slashed patients’ risk of disease progression or death by 80%, and at the 30-month mark, 82% of patients on the combo hadn’t yet seen their cancer worsen. Only 28% of the Rituxan-only group could say the same.

A combo approval could eliminate the need for chemo, a common companion in treating the disease, as well as the side effects that come along with it. And in the Innovate study, researchers found that adding Imbruvica to the mix pared down the incidence of anemia and infusion reactions that can be triggered by Rituxan use, Mark Wildgust, VP of global medical affairs for oncology at J&J’s Janssen, said in an interview at ASCO.

The Imbruvica-Rituxan marriage “significantly improves outcomes, controls disease, improves the quality of life and addresses some of those symptomatic issues right up front,” he said.

RELATED: Can AstraZeneca's Calquence really siphon share from AbbVie and J&J's Imbruvica?

Imbruvica may not be alone in Waldenström's for too much longer, though. Also at ASCO, AstraZeneca touted data from a phase 2 study of newcomer Calquence, which showed it could provoke a response in 93% of the trial’s 106 previously untreated patients.

While it’ll still take time before Calquence can threaten Imbruvica’s Waldenström's share, the AZ drug is already doing just that in mantle cell lymphoma, a go-ahead it won last October. “What we hear is when you try it, you tend to adopt it,” company executives said in an interview at ASCO, adding that, “by the end of Q1 we were gaining 25% of utilization.”

Calquence is also expected to duke it out with its fellow BTK inhibitor in chronic lymphocytic leukemia, which represents a larger market opportunity.