Culver City-based immunotherapy company ImmunityBio Inc. has taken a major step forward toward getting its first drug to market.
On July 28, the company announced that the U.S. Food and Drug Administration accepted the application of its drug to treat certain types of bladder cancer. Furthermore, the agency gave a target decision date of May 23, roughly nine months from now.
The FDA’s acceptance of this biologics license application for ImmunityBio’s drug, called Anktiva, is a major milestone. That’s because the overwhelming majority of drugs that get to this stage ultimately are approved for the market.
According to a 2021 report on clinical development success rates from 2011 through 2020, once a drug is accepted for a biologics license application review by the FDA, it has roughly a 90% chance of ultimate approval. The report was jointly sponsored by the Biotechnology Innovation Organization – the biotechnology industry’s major trade and advocacy group – the publication PharmaIntelligence, and Quantitative Life Sciences.
The same report gave a 57.8% success rate for drugs to get from completion of Phase 3 clinical trials to acceptance of the drug application for review. That’s the step that ImmunityBio just cleared.
“We are pleased the FDA has begun its review,” Richard Adcock, ImmunityBio’s chief executive, said in the announcement. “ImmunityBio is prepared to move rapidly to manufacturing and marketing should the agency approve our therapeutic for this indication.”
According to Karim Chamie, associate professor of urology at UCLA and an investigator of ImmunityBio’s bladder cancer clinical trial, ImmunityBio’s drug is only the third treatment to be developed for non-muscle-invasive bladder cancer carcinomas that don’t respond to a tuberculosis drug that is often applied to bladder cancer.
Chamie said one of the two other treatments is a chemotherapy medicine in the bladder, and the other is an immunotherapy injected into the patient’s veins.
“This drug puts a unique medicine directly into the bladder via a catheter,” which has a higher success rate than the other two drugs, Chamie said.