Culver City-based immunotherapy company ImmunityBio Inc. has gained U.S. Food and Drug Administration approval for expanded use of its primary drug Anktiva to treat a more common form of bladder cancer.
The approval, announced Oct. 14 by both the company and the FDA, came months ahead of the FDA’s decision deadline.
ImmunityBio’s share price rose 4% on the earlier-than expected news, closing on Oct. 14 at $9.91. But the stock has since given back that gain and fallen to its lowest level since Sept. 28.
The FDA initially approved Anktiva in April 2024 for use to treat a relatively rare form of non-muscle invasive bladder cancer with visible cancer cells on site. Anktiva could only be prescribed for bladder cancer patients who had not responded positively to conventional treatment with Bacillus Calmette-Guérin (BCG); it must be taken with BCG treatment. The FDA approval gave ImmunityBio its first marketable drug since the company had been launched more than a decade earlier by billionaire biotech magnate Patrick Soon-Shiong.
Within months of that initial FDA decision, ImmunityBio submitted a request for approval to the agency to use the drug to treat a more common form of bladder cancer with papillary tumors, or finger-like projections stemming from cells that line the bladder. According to the company, these papillary tumors have been found in about 85% of patients with non-muscle invasive bladder cancer.
But in early 2025, the FDA rejected this expanded use application, asking ImmunityBio to submit more data backing the case for expanded use. ImmunityBio submitted the data and last May the FDA said it would decide again on the expanded use by Jan. 6, 2027.
Instead, the FDA ruled this month, much to the delight of ImmunityBio executives.
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