J&J, AbbVie's Imbruvica breaks into larger CLL market with first-line FDA nod

Johnson & Johnson ($JNJ) and AbbVie ($ABBV) have snagged the indication for standout cancer med Imbruvica that they've been waiting for.

On Friday, the FDA granted the pair a first-line nod in chronic lymphocytic leukemia (CLL) based on results of a Phase III trial in which the med cut the risk of disease progression or death by 84% compared with chemo treatment chlorambucil.

It's a win for the companies, which already had indications for Imbruvica in previously treated CLL patients, as well as those with previously treated mantle cell lymphoma and those with Waldenström macroglobulinemia. And the companies are hoping the list won't end there, with an eye on potentially expanding into other B-cell malignancies like multiple myeloma.

But AbbVie, for one, expects nearly a third of Imbruvica's forthcoming growth to come from moving into earlier lines of therapy the way it'll now be able to do in CLL. First-line label expansions bring along larger groups of patients who stay on treatments for longer periods of time; in the U.S., 15,000 new CLL patients are diagnosed every year, the companies said in a statement.

And AbbVie was counting on that potential when it agreed last year to shell out $21 billion to buy J&J partner Pharmacyclics--a sum analysts pegged as "lofty," "staggering," and even "astronomical." The Illinois pharma predicts the med will be able to haul in at least $7 billion for the company at its peak, a number that calculates out to about $11.5 billion to $12 billion in end-user sales, Evercore ISI analyst Mark Schoenebaum has projected.

- read the release

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