Genmab (CPH:GEN) has moved a step closer to seeing daratumumab approved in double refractory multiple myeloma. A rolling submission for the breakthrough cancer therapy is now underway, raising hopes that the product will be on the market early next year.
|Genmab CEO Jan van de Winkel|
Such hopes are underpinned by the FDA's recent track record of approving cancer drugs in double-quick time, which SydBank analyst Soren Lontoft thinks could result in the licensing process taking just four months. Amgen's ($AMGN) Blincyto and Novartis' ($NVS) Zykadia both passed across the desks of FDA officials at a similar rate. If Genmab and Johnson & Johnson ($JNJ) can follow in their tire tracks, daratumumab could come to market in the U.S. in the first half of next year. And with analysts at Jefferies tipping the drug to peak at annual global sales of $4 billion (€3.5 billion), that prospect has investors salivating.
Shares in Genmab ticked up another few percentage points in the wake of the news, moving its total gains in 2015 up to 68%. Over the past calendar year the stock is up more than 160%. The rapid rise is the result of growing belief in the strength of daratumumab, which impressed again with Phase II data at ASCO. Daratumumab appears to help multiple myeloma patients who have run out of other treatment options. And with rival drugs from MorphoSys (ETR:MOR) and Sanofi ($SNY) trailing in the distance, Genmab and J&J have a window in which to sew up the market.
The partners are building their FDA submission around the Phase II data presented at ASCO in patients who had already received three lines of treatment or more. Safety and efficacy data from a Phase I/II trial and three other studies are also being included. Further down the line, Genmab and J&J are keen to maximize the use of daratumumab by having it oust Takeda's Velcade from its slot as the go-to first-line therapy. J&J began work on a Phase III trial of daratumumab as a first-line therapy last year and studies of it in combination with Velcade and Celgene's ($CELG) Revlimid are also active.
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