- In April 2024, Ferring Pharmaceuticals and its U.S.-based subsidiary FerGene advanced commercialization efforts for Adstiladrin (nadofaragene firadenovec), a gene therapy approved by the FDA for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The therapy delivers the interferon alfa-2b gene directly into the bladder lining, offering a novel mechanism for immune activation. This milestone signifies a transformative step in bladder cancer care, providing an effective bladder-preserving alternative for high-risk patients lacking options beyond radical cystectomy
- In March 2024, ImmunityBio, Inc. received FDA approval for Anktiva (nogapendekin alfa inbakicept), an IL-15 superagonist used in combination with BCG for patients with BCG-unresponsive NMIBC. This approval marked the second immunotherapy-based alternative to BCG in this niche, targeting immune stimulation pathways to boost the body’s ability to clear cancer cells intravesically. The launch reflects growing regulatory momentum and clinical demand for novel immunotherapies in urologic oncology
- In February 2024, CG Oncology initiated Phase 3 clinical trials for CG0070, an oncolytic immunotherapy designed to selectively replicate in and kill bladder cancer cells while stimulating anti-tumor immune responses. The trial targets patients with high-risk NMIBC unresponsive to BCG, reinforcing the company’s focus on developing intravesical oncolytic viral therapies. This highlights the pipeline expansion and competitive innovation landscape within bladder-sparing treatments
- In January 2024, The U.S. National Cancer Institute (NCI) partnered with multiple academic centers to launch a multicenter clinical program evaluating combination intravesical regimens involving gene therapy and immune checkpoint inhibitors for NMIBC. The initiative reflects a broader shift toward synergistic therapies aiming to enhance efficacy while minimizing systemic exposure, furthering precision oncology within the bladder cancer therapeutics space
- In December 2023, Qilu Pharmaceutical (China) announced early-phase clinical results for its proprietary intravesical chemotherapy combination for intermediate-risk NMIBC patients. With promising outcomes in recurrence reduction and bladder preservation, the company is preparing for international regulatory submissions, signaling the global expansion of innovation beyond Western markets and increasing therapeutic accessibility in Asia-Pacific regions
