Newly Approved Bladder Cancer Therapy First Commercial Doses Administered

ImmunityBio, Inc. today announced the initial treatment of multiple patients in the U.S. to receive therapy with ANKTIVA®, the company's recently approved immunotherapy for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ.

The first bladder cancer patients to receive commercial doses are located throughout the U.S., and several are being treated by community urologists, as the therapy does not require any special handling or equipment that would limit its use to specialty medical centers.

ANKTIVA  (nogapendekin alfa inbakicept-pmln) was approved by the U.S. Food and Drug Administration (FDA) on April 22, 2024, for the treatment of patients with BCG-unresponsive NMIBC CIS with or without papillary tumors.

The intravesical therapy employs a combination of ANKTIVA, an IL-15 agonist, in combination with the BCG vaccine.

The combination is the first FDA-approved immunotherapy in NMIBC that functions by activating the body’s NK and killer T-cell immune system to attack tumor cells while simultaneously activating memory T cells, leading to a prolonged duration of complete response exceeding 47 months for some patients.

“In addition to its unique mechanism of action, ANKTIVA can be readily administered by urologists in their own offices and clinics, enabling more patients to receive it in familiar settings from their own providers,” said Richard Adcock, President and CEO of ImmunityBio, in a press release on June 20, 2024.

“We look forward to ANKTIVA reaching more and more eligible NMIBC patients and for our science to deliver even more therapies from our pipeline.”

In May 2024, ImmunityBio announced it had drug substance sufficient for 170,000 doses of ANKTIVA for commercial and clinical trial use.

In the U.S., the American Cancer Society estimates there will be 83,190 new cases and 16,840 deaths from bladder cancer in 2024.