Culver City-based ImmunityBio Inc. announced a couple of key developments last month that it hopes will eventually boost sales for its signature Anktiva drug to treat certain forms of bladder cancer.
On May 18, ImmunityBio said in a statement that the U.S. Food and Drug Administration has accepted for review the company’s application for expanded use of Anktiva, with a decision deadline of next Jan. 6.
The FDA’s initial approval two years ago was for treatment of certain types of bladder cancers that have tumors with finger-like projections but don’t respond to treatment with bladder cancer therapy BCG. The expanded use is for bladder conditions with similar tumors. Yet those tumors may be pre-cancerous.
“Anktiva is already approved for patients with CIS (cancer in situ) with or without papillary disease, and this application has the potential to expand access to patients with papillary-only disease, the larger segment of the BCG-unresponsive population,” Richard Adcock, ImmunityBio’s chief executive, said in a statement.
Anktiva is designed to be administered only after bladder patients are treated with a specific type of bacterium known as Bacillus Calmette-Guerin, or BCG for short, and that treatment is not successful in slowing or reversing the growth of the cancer.
Purchasing BCG strain
The BCG bacterium is at the center of another significant development ImmunityBio reported last month.
On May 16, ImmunityBio said it had acquired a strain of the BCG treatment from Tokyo-based Japan BCG Laboratory for an undisclosed sum. That particular strain has been used for three decades to treat forms of bladder cancer.
According to the announcement, the agreement provides ImmunityBio exclusive U.S. rights to develop, import and commercialize the bacterial strain. This includes getting FDA approval of the BCG strain for use in the United States.
“We are pleased to partner with ImmunityBio to bring the Tokyo strain of BCG to patients in the United States, and we look forward to supporting ImmunityBio in its engagement with the FDA,”
Seiichi Inoue, president of Japan BCG Laboratory, said in a statement.
The acquisition of this strain in effect gives ImmunityBio more vertical control of the treatment process in the U.S. for the types of bladder cancer that Anktiva targets.
