J&J, AbbVie's Imbruvica pads CLL lead with FDA green light in younger patients

Imbruvica bears six approvals in chronic lymphocytic leukemia and 11 approvals overall. (AbbVie)

Many chronic lymphocytic leukemia (CLL) patients start out on Johnson & Johnson and AbbVie’s Imbruvica, a blockbuster that until recently had five indications in the disease. Thanks to a sixth granted by the FDA Tuesday, younger, fitter patients can now start on it, too.

The agency green-lighted a combination of Imbruvica and Roche’s Rituxan in patients 70 or younger who have yet to try other therapies. Historically, patients in that group “who were fit enough to tolerate an aggressive treatment course” have received a chemo cocktail called FCR, for fludarabine, cyclophosphamide and rituximab, Brian Koffman, M.D., CLL Society’s chief medical officer, said in a statement.

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But in a phase 3 trial, the Imbruvica-Rituxan pairing showed it could best that regimen. At the 37-month mark, 88% of patients taking the Imbruvica combo hadn’t seen their cancer worsen, compared with 75% of FCR patients.

“This is the gold standard, most efficacious, potent therapy that we had in CLL up until this point,” Danelle James, M.D., head of clinical science at AbbVie’s Pharmacyclics, said of FCR in late 2018, when the companies unveiled the study’s first phase 3 data. “To really take out the gold standard is a great place to be in, in terms of having that proof and that evidence for physicians and patients.”

Imbruvica, which the companies have shared since AbbVie’s 2015 Pharmacyclics buyout, is a powerhouse in the CLL field. The study that yielded the drug’s latest approval was the fourth phase 3 trial to read out in Imbruvica’s favor.

“They have almost mutually exclusive populations, but they cover the entire spectrum of CLL,” James said at the time, adding that, in “the front-line setting, it’s almost like no patient left behind.”

RELATED: AstraZeneca's Calquence steps up to challenge Imbruvica with big CLL green light

But thanks to a pair of in-class rivals, things have gotten more interesting lately. In November, AstraZeneca’s Calquence scored its first go-ahead in previously untreated CLL patients, setting it up to take on Imbruvica in its biggest market.

And shortly thereafter, analysts liked what they saw in a head-to-head trial between Imbruvica and BeiGene’s Brukinsa. While the trial was testing the drugs in Waldenstrom macroglobulinemia, Wall Streeters used it to gauge Brukinsa’s prospects in the much larger CLL field.