Building on some solid data, AbbVie and J&J today landed an FDA OK to sell a chemo-free combination of their BTK inhibitor Imbruvica with Roche’s Rituxan for a rare and incurable type of non-Hodgkin’s lymphoma.
The agency came through after researchers posted an 82% survival rate after 30 months for patients with Waldenström’s macroglobulinemia — only 28% patients getting only Rituxan survived that long.
The FDA’s OK came two months ahead of the PDUFA date for this indication, spotlighting the agency’s comfort with rapidly pushing through approvals — particularly when it comes to oncology.
The approval marks the 9th green light offered Imbruvica, where marketers are looking to jump out ahead of AstraZeneca’s BTK inhibitor Calquence as it looks to compete for this group of patients. AstraZeneca won its first nod to sell Calquence last fall for mantle cell lymphoma, a rare B-cell non-Hodgkin lymphoma. And now researchers for the company are actively pushing into new indications for their showdown with AbbVie and J&J, hoping to eventually break into the blockbuster ring with $1 billion-plus in sales.
In AstraZeneca’s Phase II investigators tracked an impressive 93% response in previously untreated patients.
But AstraZeneca faces some of the toughest competitors in drug marketing. AbbVie reported that Imbruvica hit $2.6 billion in revenue last year, with $5 billion expected in 2020 and peak sales estimates set at $7 billion. And this new chemo-free approach to therapy will likely gain some quick adherents.
“The approval of ibrutinib and rituximab has added a new option for many Waldenström’s patients,” said Steven Treon, the lead investigator of the Imbruvica Phase II clinical trial which served as the basis for its January 2015 FDA approval.
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