ImmunityBio bags elusive label extension for Anktiva

ImmunityBio has finally crossed the finish line in its marathon bid to get the label for its bladder cancer therapy, Anktiva, expanded in the US.

The FDA has approved the IL-15 receptor agonist – in combination with the BCG vaccine – as the first treatment for papillary-only non-muscle invasive bladder cancer (NMIBC) that has not responded to prior BCG therapy.

Anktiva (nogapendekin alfa inbakicep) has been approved since 2024 for use in combination with BCG in NMIBC patients who have not responded to the BCG shot on its own and have carcinoma in situ (CIS), with or without papillary tumours.

It's an important development for ImmunityBio, as papillary disease represents approximately 85% of the NMIBC patient population, so the broader label dramatically expands Anktiva's commercial potential.

The drug made $113 million in sales last year, up from $14 million in 2024, and analysts reckon the new approval could usher the drug toward blockbuster status, with GlobalData recently predicting that it could make peak sales of $4 billion by 2032.

The FDA said its decision – which comes three months ahead of the action date for the marketing application – marks a new approach to evaluating treatments for BCG-unresponsive NMIBC that has allowed ImmunityBio to secure approval based on "scientific similarities between CIS and high-grade papillary-only disease."

That has bypassed the need for a full-blown phase 3 trial, and comes around 18 months after the agency refused to accept a marketing application for Anktiva without an additional study.

The approval may be something of an irritant for Johnson & Johnson, which sells a competing product – Inlexzo (gemcitabine intravesical system; formerly TAR-200) – in the CIS setting.

J&J has encouraging data for Inlexzo in BCG-unresponsive, papillary-only NMIBC from a cohort of the phase 3 SunRISe-1 study, but opted to run a second, dedicated pivotal trial – SunRISe-5 – that is due to read out before the end of the year and will form the basis of its filing to expand the product's label.

The FDA's turnaround on Anktiva and swift verdict hands ImmunityBio several months to establish its drug in the new setting before Inlexzo reaches the market, assuming the SunRISe-5 readout is positive.

"We listen to patients, clinicians, and researchers, and we act when the science supports a new approach," said Angelo de Claro, director of the FDA's Oncology Center of Excellence.

"For Anktiva, our review of the similarities between these cancers allowed us to build on the results in patients with CIS and expand treatment options for people with high-grade papillary tumours alone," he added. "This approach may also help guide the development of future treatments."

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