J&J sets sights on bigger Darzalex market with FDA 'breakthrough' in second-line myeloma

So far, the group of newly approved multiple myeloma meds hasn’t proved much of a threat to older, more established therapies. But that could all change soon.

Johnson & Johnson's Darzalex now has a chance to leapfrog into second-line use, a much bigger market than its current approved indication. The drug nabbed the FDA's Breakthrough Therapy Designation as a treatment for multiple myeloma patients who've relapsed after at least one prior therapy, the company said Tuesday.

In these patients, Darzalex would be combined with the chemo drug dexamethasone and either Celgene’s Revlimid or Takeda’s Velcade.

Right now, Darzalex is restricted to the fourth-line setting, meaning patients don’t get a crack at it until they’ve failed on three or more previous regimens. If this new designation leads to a speedy thumbs up from regulators, Darzalex’s patient pool will swell considerably--and bring in patients who tend to stay on therapy for longer periods of time.

It’s a prospect that would certainly please J&J, which is battling it out in the next-gen field with Takeda’s Ninlaro and Bristol-Myers Squibb and AbbVie’s Empliciti. All three meds were approved late last year, and so far they’ve been toiling with market shares in the single digits, Amgen commercial EVP Tony Hooper told investors on the company’s Q1 conference call.

But if J&J does snag a second-line nod, that'll put the heat on Amgen's Kyprolis, which only recently won its own second-line green light.  And stiffer competition is the last thing Kyprolis needs. The Big Biotech's med hasn't started off as strongly as Amgen had expected when it shelled out $10 billion for maker Onyx in 2013.

Meanwhile, J&J isn’t just relying on moving up into earlier lines of therapy to keep the Darzalex expansion coming. Earlier this year, J&J announced it would team up with Roche to test its cancer-fighter with Tecentriq, a brand-new PD-L1 immunotherapy from Roche’s Genentech unit.

- read J&J's release

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