‍FDA Grants Approval to ImmunityBio's Treatment for Bladder Cancer

In a significant development, the U.S. health regulatory body has granted approval for ImmunityBio's innovative combination therapy aimed at addressing a specific form of bladder cancer. This decision marks a pivotal moment for ImmunityBio, putting an end to its persistent efforts to introduce the therapy to the market. The company's recent concerns about its commercial viability, as expressed in a regulatory filing just last month, are now alleviated with the agency's favorable verdict. Notably, the FDA's previous denial of clearance for the therapy, Anktiva, due to identified deficiencies during pre-license inspections of the company's contract manufacturing partners, underscores the arduous journey leading to this approval.

The mechanism of action for this therapy involves the activation of specific immune cells, namely natural killer (NK) cells and T-cells, which play crucial roles in combating diseases. By stimulating these immune cells, the therapy aims to establish lasting immunity within the body.

According to ImmunityBio, the availability of Anktiva in the U.S. markets is anticipated by mid-May 2024. However, the company has not provided details regarding the pricing of the therapy as requested.

Anktiva is designed to be used in conjunction with the Bacillus Calmette-Guérin (BCG) vaccine. While primarily known for its efficacy against tuberculosis, the BCG vaccine also serves as a common treatment option for certain types of bladder cancer.

The combination therapy targets patients afflicted with a specific type of bladder cancer that fails to respond to the vaccine and remains localized. According to ImmunityBio, this subgroup constitutes approximately 75-85% of bladder cancer patients.

Presently, bladder cancer patients typically undergo surgical ablation, followed by either chemotherapy or administration of the BCG vaccine as part of the standard treatment regimen.

In recent years, Merck's Keytruda has gained approval for the treatment of bladder cancer. However, as noted by ImmunityBio's executive chairman, Patrick Soon-Shiong, there remains a risk of cancer recurrence despite such treatments.

ImmunityBio's ambition, as articulated by Soon-Shiong, is to achieve long-term overall survival free from cancer, surpassing the conventional focus on short-term responses in cancer care.

Results from a subset of 83 patients in a late-stage study revealed promising outcomes for the combination treatment. Notably, 71% of patients experienced complete tumor disappearance, with a median duration of response reaching 24.1 months. These findings underscore the potential efficacy of the therapy in combating bladder cancer.

Source: Reuters