FDA Approves ANKTIVA® for BCG-Unresponsive Bladder Cancer

ImmunityBio, Inc. (NASDAQ: IBRX), a leader in immunotherapy, has just received FDA approval for ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG). This approval marks a significant advancement in the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), regardless of the presence of papillary tumors.

ImmunityBio, Inc. (NASDAQ: IBRX) has announced the FDA approval of ANKTIVA, a groundbreaking immunotherapy, for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. Dr. Patrick Soon-Shiong, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, expressed enthusiasm about ANKTIVA’s novel mechanism of action, which not only activates the patient’s own NK cells and CD8+ killer T cells but also enhances the proliferation of memory killer T cells. This innovative approach, resembling the biology of dendritic cells, signifies a pivotal step forward in immunotherapy, extending beyond T cells alone.

The approval of ANKTIVA, a first-in-class IL-15 agonist immunotherapy for NMIBC, was granted Breakthrough Therapy Designation by the FDA based on promising safety and efficacy outcomes, particularly in terms of complete response (CR) rates and duration (DOR). In a single-arm, multicenter trial involving 77 evaluable patients who received ANKTIVA with BCG maintenance therapy for up to 37 months, the CR rate was an impressive 62%, with a duration of complete response exceeding 47 months as of the November 2023 cut-off.

These remarkable results surpass the benchmarks set by the International Bladder Cancer Group (IBCG) for durable complete response, indicating a significant advancement in NMIBC treatment. Dr. Karim Chamie, Associate Professor of Urology at UCLA and principal investigator for the QUILT 3.032 study, emphasized the potential of ANKTIVA to redefine the standard of care for NMIBC and improve outcomes for patients.

Bladder cancer patients, especially those with NMIBC facing limited treatment options after BCG failure, now have renewed hope with ANKTIVA’s approval. By enhancing natural killer cell recruitment and T cell stimulation, ANKTIVA offers a potent and effective alternative to radical surgeries, significantly improving the long-term prognosis for patients.

The safety profile of ANKTIVA, consistent with that of BCG alone, further supports its potential as a preferred treatment option for NMIBC. Ongoing studies in both BCG-unresponsive and BCG-naive patients aim to provide additional insights into its efficacy and safety profile.

Looking ahead, Dr. Soon-Shiong highlighted the broader potential of ANKTIVA beyond NMIBC, with ongoing trials across various tumor types. As research progresses, ANKTIVA may emerge as a cornerstone in the development of cancer vaccines and preventive therapies, offering new possibilities for patients worldwide.

ANKTIVA is anticipated to be available in the U.S. by mid-May 2024, offering new hope and improved outcomes for patients battling bladder cancer. ImmunityBio remains committed to supporting patient access through its Patient Assistance Program, ensuring that all individuals in need can benefit from this innovative treatment.

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