ImmunityBio’s ANKTIVA Gains Permanent J-Code For Bladder Cancer Treatment

The US-based biotech and immunotherapy company ImmunityBio announced that there is now a permanent HCPCS J-code applicable to ANKTIVA for January 1, 2025. This distinct J-code, J9028, enables the ANKTIVA billing and reimbursement processes in healthcare and can be given intravesically at one microgram strength.

Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, said, “The unique J-code for ANKTIVA is another milestone in our quest to deliver the next generation of immunotherapy beyond T cell activation and enables patients with bladder cancer to benefit from the power of natural killer (NK) cells.”

ANKTIVA, approved by the U.S. Food and Drug Administration (FDA) in 2024, is used in combination with Bacillus Calmette-Guérin (BCG) to treat adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.

Richard Adcock, President and CEO of ImmunityBio, said, “In approximately 30-40% of patients with NMIBC, standard therapy with BCG will fail, while in 50% of patients who initially respond to BCG, their cancer will come back. This permanent J-code supports our efforts to increase patient access to ANKTIVA, which in our ongoing QUILT 3.032 study demonstrated a 71% complete response rate in patients with BCG-unresponsive NMIBC CIS, as of November 2024, with a duration of response of up to 54 months.”

Since its launch in May 2024, ANKTIVA has been made widely accessible to patients, with coverage secured for over 200 million individuals through commercial and government insurance programs, including Medicare, the Department of Veterans Affairs (VA), and the Department of Defense (DoD).