Legend improves access to Carvykti, but cell therapy lags demand as biotech seeks earlier-line approval
Legend Biotech and its partner Johnson & Johnson are seeking approval to move their blood cancer cell therapy into earlier lines of treatment, though the companies have struggled so far to catch up to market demand.
The New Jersey biotech said Tuesday that the FDA will conduct a standard review, rather than a speedy one, as it seeks approval for Carvykti as a second treatment option for patients with multiple myeloma. The FDA set a decision deadline of April 5, 2024, and European regulators also accepted the application for an expanded label.
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