UPDATED: J&J's Darzalex posts 'standout' data in myeloma, nabs FDA priority review

Darzalex

Johnson & Johnson may have a hotter med in Darzalex than previously thought. Already approved for multiple myeloma patients who’ve failed on three previous regimens, new data further illuminate the case for Darzalex as a treatment for patients at all stages of the disease, experts said.

As results from the closely watched POLLUX trial hit the New England Journal of Medicine Thursday, two myeloma experts called a Darzalex combo therapy a “clear standout.” The study showed that the rate of complete response--no sign of cancer after therapy--was 43.1% in patients on a Darzalex cocktail, compared with 19.2% for patients taking Celgene’s Revlimid and the standard med dexamethasone.

And Friday, the FDA put additional fuel behind a potential new "triple therapy" indication--based on this and a previously released test with a different Darzalex combo. The agency granted the J&J med priority review for that expanded use, with a decision target of Feb. 17.

In addition to solid response rates, the 569-patient POLLUX trial showed that the Darzalex combo kept myeloma at bay for longer than the two-drug regimen did. It cut the risk of disease progression an impressive 63% compared with the two-drug approach. And the overall response rate in the Darzalex group was 93%, compared with 76% in the control arm.

With the priority review tag, Darzalex will get a quick hearing on an approval for second-line use--in patients who’ve failed on just one therapy--as part of two different three-drug cocktails. POLLUX investigators studied the Revlimid-based version, while a different trial, CASTOR, focused on the other, which compared Darzalex to Takeda’s Velcade and dexamethasone.

If the agency gives its blessing, Darzalex’s patient pool would swell considerably--and bring in patients who tend to stay on therapy for longer periods of time.

In an NEJM commentary published alongside the newly unveiled study data, two Mayo Clinic authors called Darzalex (daratumumab) a “landmark advance” and predicted the drug will become a standard myeloma treatment over the next few years.

"The magnitude of benefit is impressive, and the regimen is relatively easy to administer, especially after the first 6 months of therapy," wrote Dr. S. Vincent Rajkumar and Dr. Robert A. Kyle.

A second-line nod for Darzalex would 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.

Related Articles:
J&J sets sights on bigger Darzalex market with FDA 'breakthrough' in second-line myeloma
J&J's Darzalex slashes risk of myeloma progression by more than 60%
Amgen's Kyprolis stands its ground against new J&J, BMS rivals
Looking to build Darzalex a bigger market, J&J teams up with Roche for atezo combo trials
J&J undercuts Celgene's Pomalyst with $135K-per-year Darzalex price

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