Johnson & Johnson's Darzalex snags landmark myeloma approval in first-line patients

The new FDA approval for Darzalex is its fifth in multiple myeloma. (J&J)

Johnson & Johnson’s Darzalex just vaulted ahead of its myeloma competitors—and it has plenty of them.

Monday, the FDA greenlighted the drug—in combination with Takeda’s Velcade and prednisone—in first-line multiple myeloma patients who are transplant ineligible, making it the first monoclonal antibody to ring up an approval in newly diagnosed patients.

The go-ahead is no surprise, considering the stellar data J&J unveiled at December’s American Society of Hematology annual meeting. In a trial of front-line patients, at a median follow-up of 16.5 months, the Darzalex regimen cut the risk of disease progression or death by 50%.

Watch the Free Webinar

Chemistry Through Biology: Translating Molecular Biology Technologies into Practical Processes for API Production

Learn about the key advances and critical hurdles in transforming emerging molecular biology technologies into practical applications with commercially viable processes.

Darzalex has come a long way since its first approval back in late 2015, which came the same month Bristol-Myers Squibb’s Empliciti and Takeda’s Ninlaro picked up their own FDA blessings. The J&J product was initially cleared only for patients who had tried three prior treatments, and it snagged its second-line OK a year later.

RELATED: J&J's Darzalex leaps ahead in multiple myeloma lineup with new FDA approval

Meanwhile, the newest approval marks Darzalex’s fifth in myeloma—and the way J&J’s executives see it, there are plenty more to come, including in the front-line setting.

“What we’ve seen is that the drug seems to benefit with any regimens—with other IMiD-containing regimens, with proteasome regimens ... so our general view is that this is a mechanism that can improve on [results from] any established regimen,” Peter Lebowitz, Janssen’s global therapeutic area head of oncology, said in an interview at ASH.

The company’s Janssen unit is currently trialing the hot-shot drug in other front-line studies, one of which is examining Darzalex in combination with an IMid therapy and a proteasome inhibitor. “We want it to be fairly universal that you use the drug with whatever regimen you end up choosing,” Lebowitz said.

Suggested Articles

Which rollouts might suffer most? Those that treat chronic diseases, require doctors to administer them or face current competition, analysts say.

Novartis and Incyte will put their blockbuster JAK inhibitor into phase 3 clinical trials as a possible treatment for COVID-19, the drugmakers said.

The Cannes Lions canceled its advertising creativity conference for 2020 after media reports that many large ad agencies planned to opt out.