On 19 January 2018, the US Food and Drug Administration (FDA) recommended that Darzalex (daratumumab) be granted Priority Review as a frontline regimen in Multiple Myeloma (MM). This follows the presentation of data from the phase III ALCYONE trial at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition in 2017 as a late-breaking abstract, as well as the timely publication of the data in the New England Journal of Medicine in December 2017.
The recommendation is that daratumumab can be given in combination with bortezomib, melphalan and prednisone (abbreviated as D-VMP) to treat patients with newly diagnosed (ND) MM who are ineligible for autologous stem cell transplant (ASCT). A full decision is expected by 21 May 2018.
The ALCYONE study enrolled 706 patients and yielded highly impressive data, with a 50% reduction in the risk of progression or death with daratumumab (HR = 0.5), when combined with the SOC regimen of VMP alone.
This move towards daratumumab as a frontline regimen is exciting, as it opens up the possibility of much wider use across all stages of the disease. Indeed, given that much of the data presented at ASH 2017 indicated that ‘everything is better with daratumumab’, it is likely we will see the indications for daratumumab expand further in the coming months. This will certainly be welcome news for both Genmab and Janssen, who develop the drug together, as well as transplant ineligible patients who will now have wider options.