What's Happening?
ImmunityBio has announced a significant development in its efforts to expand the use of its bladder cancer therapy, Anktiva, following discussions with the FDA. The company plans to refile for approval to use Anktiva in high-grade papillary-only non-muscle
invasive bladder cancer (NMIBC) that is unresponsive to BCG, a group currently lacking approved targeted therapies. Anktiva, an IL-15 receptor agonist, is already approved for use with the BCG vaccine in NMIBC patients with carcinoma in situ. The proposed label expansion would allow treatment of a broader patient group, potentially increasing Anktiva's market reach. The decision follows promising data from the QUILT-3.032 trial, showing high disease-free and disease-specific survival rates.
Why It's Important?
The potential label expansion for Anktiva could provide a new treatment option for patients with high-grade papillary-only NMIBC, a condition with limited therapeutic options. This development could significantly impact the bladder cancer treatment landscape, offering hope to patients who do not respond to existing therapies. The expansion could also drive growth for ImmunityBio, which reported $113 million in sales for Anktiva last year. The company's ability to secure FDA approval without initiating new clinical trials underscores the strength of its existing data and could expedite the availability of this treatment to a wider patient population.
What's Next?
ImmunityBio plans to submit additional data to the FDA within the next 30 days to support the resubmission for the expanded use of Anktiva. The company aims to leverage the promising results from the QUILT-3.032 trial to gain approval for the new indication. If successful, this could enhance ImmunityBio's competitive position in the bladder cancer market, where it faces competition from Johnson & Johnson's Inlexzo. The outcome of this regulatory process will be closely watched by stakeholders, as it could set a precedent for future label expansions based on existing clinical data.
