J&J, Genmab bag breakthrough status for Darzalex, shortening route to second-line use

FDA staffers have joined the long list of people to be impressed by data on Johnson & Johnson ($JNJ) and Genmab’s (CPH:GEN) cancer drug Darzalex. The regulator recently took a look at data from trials that gave Darzalex in combination with Celgene’s ($CELG) Revlimid and Takeda’s Velcade, after which it granted breakthrough therapy status to the drug as a second-line treatment for multiple myeloma.

CD38 monoclonal antibody Darzalex is approved as a third-line therapy in multiple myeloma--an indication in which it picked up a breakthrough status in 2013--but has yet to be submitted for approval for use earlier in the treatment pathway. The fact that a supplemental BLA would be submitted, and that Darzalex would likely capture a chunk of the expanded market when approved, has been evident since J&J and Genmab posted data from a pair of Phase III trials earlier this year. Now, having looked over the data, the FDA has opened the door to a quickie approval.

The breakthrough designation is designed to accelerate the advance of drugs that have generated data showing substantial improvements over existing therapeutic options. Having aced Revlimid and Velcade in Phase III trials, Darzalex fits this description, resulting in it snagging a breakthrough status that could see it undergo accelerated review at the FDA. When the FDA approved Darzalex for use in heavily pretreated or double refractory multiple myeloma patients in November, it revealed its decision just two months after receiving the BLA.

Another swift decision on the supplemental BLA could result in J&J starting to market Darzalex in combination with Revlimid and Velcade from early next year. Genmab CEO Jan van de Winkel has previously said he expects J&J to submit an application in the third quarter. As the FDA is familiar with Darzalex, the Phase III data are compelling and the regulator has already awarded a breakthrough designation, the expectation is that the path from filing to approval will be swift and simple. Shares in Genmab rose 5% following news of the breakthrough status.

The rise, which moved Genmab above the DKK 1,200 ($178)-a-share mark it first cleared on the back of the Phase III data, is underpinned by a belief that Darzalex will grow into a blockbuster. Revlimid racked up sales of $5.8 billion for Celgene last year, a figure some analysts think Darzalex can top if it becomes established as a backbone therapy in multiple myeloma. That prospect could be good for J&J, Genmab and patients, but is likely to send shivers down the spines of payers. With Revlimid costing upward of $100,000 a year, the combination with Darzalex could clear $250,000.

- read the release

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