FDA clears ImmunityBio’s bladder cancer drug at 2nd attempt


After rejecting ImmunityBio’s Anktiva last year, the FDA has cleared the drug as a treatment for bladder cancer, making it the company’s first commercial-stage product.

Anktiva (nogapendekin alfa inbakicep, or N-803) can be used in combination with the BCG vaccine in non-muscle invasive bladder cancer (NMIBC) patients who had not responded to the BCG shot on its own, according to the FDA, which blocked the drug last year because of quality issues at a contract manufacturing plant used to make it.

The decision throws a lifeline to ImmunityBio, which refiled the drug last October and previously said it may struggle to remain in business if the FDA turned it down for a second time.

Anktiva is billed as a first-in-class IL-15 receptor agonist that activates natural killer (NK) and T-cell cells in the body to attack tumours, as well as memory T cells to extend the duration of that response. It can be used as maintenance therapy with BCG for up to 37 months in adults with NMIBC.

Borrowing from basketball terminology, ImmunityBio’s chairman and chief scientific and medical officer, Patrick Soon-Shiong, said Anktiva’s mechanism is a ‘triangle offence’ that “begins the evolution of immunotherapy beyond T cells alone.”

There are few treatment options for patients who develop BCG-unresponsive bladder cancer, which raises the risk of the cancer spreading throughout the body. Around 40% of patients don’t respond to BCG, and many go on to have their bladder removed to try to limit the disease.

In the QUILT 3.032 trial, Anktiva plus BCG achieved a complete response rate of 71%, a median duration of response of almost 27 months, and a 90% reduction in the need for bladder removal surgery.

Anktiva becomes another option for BCG-unresponsive BMIBC patients alongside MSD/Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) – approved by the FDA in 2020 – and Ferring Pharma’s gene therapy Adstiladrin (nadofaragene firedenovec), which was cleared in 2022.

Further competition for Anktiva could also be on the way from CG Oncology, a recent Nasdaq debutante whose lead drug candidate, cretostimogene grenadenorepvec, is in phase 3 for BCG-unresponsive NMIBC.

ImmunityBio said its Anktiva should be launched in the US market next month, but hasn’t yet disclosed its pricing plans.

It is also developing the drug for BCG-unresponsive NMIBC with high-grade papillary disease, BCG treatment-naïve NMIBC, several other oncology indications across solid tumours and blood cancers, and HIV.