Johnson & Johnson (NYSE:JNJ), Genmab Get New FDA Breakthrough Designation

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Johnson & Johnson (NYSE:JNJ) and Genmab’s Darzalex has received a new breakthrough therapy designation from the US Food and Drug Administration (FDA) as a second-line treatment for multiple myeloma. The regulators took a look at data from Darzalex used in combination with Celgene Corporation (NASDAQ:CELG) Revlimid and Takeda’s Velcade and were impressed with the results.

The breakthrough designation granted is for the use of Darzalex in combination with dexamethasone and lenalidomide, or dexamethasone and bortezomib for the treatment of patients with multiple myeloma and has received at least one prior therapy.

The breakthrough designation is designed to try and accelerate the advancement of drugs that have trial results data showing substantial improvement compared to existing therapeutic options. Having outclassed Revlimid and Valcade in the phase III trials has earned the breakthrough status that could see it undergo accelerated review at the FDA.

Darzalex is approved as a third-line therapy in multiple myeloma – an indication in which it picked up a breakthrough status back in 2013. The drug is yet to be submitted for approval for use. It was evident that Darzalex would likely capture a big percentage of the expanded market after it posted positive results during Phase III trials earlier this year. The FDA has now opened the door for a quicker approval of the drug.

Genmab CEO, Jan van de Winkel, in the past noted that he expects Johnson & Johnson to submit an application in the third quarter, as the FDA is already familiar with Darzalex Phase III data, which have made regulators issue a breakthrough designation for the drug. He further noted that it is expected that the path from filing to approval will be swift and straightforward.

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