J&J bids for EU OK on Legend CAR-T; FDA extends review period for Ardelyx's phosphorus control drug
J&J may be on its way to its first cell therapy approval on two continents.
The big pharma announced on Friday that they had applied for the EU to approve the CAR-T therapy for multiple myeloma they are co-developing with Nanjing-based Legend Biotech. The therapy is now sitting before regulators in both Europe and the US, where J&J started a rolling submission in January.
The applications put the CAR-T on track to complete a meteoric rise to market next year and compete with a rival therapy from bluebird bio and Bristol Myers Squibb that goes after the same cancer receptor, BCMA, but has shown significantly worse efficacy in clinical trials.
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