Disease states / Non-muscle-invasive Bladder Cancer

Treatment Landscape Evolutions

Non-muscle-invasive Bladder Cancer

INLEXZO (gemcitabine intravesical system)

FDA Approval: 2025

Chemotherapy

TAR-200 is a DNA replication inhibitor. It is an intravesical, continuous-release form of the nucleoside analog chemotherapy agent gemcitabine.1

ANKTIVA (Nogapendekin alfa inbakicept-pmin [NAI]) in combination with BCG

FDA Approval: 2024

Immunotherapy

Nogapendekin alfa inbakicept-pmin (NAI) is an interleukin-15 (IL-15) receptor agonist1 and is often described as an IL-15 superagonist.2 It binds to its receptor on the surface of CD-4+ and CD-8+ T cells and natural killer (NK) cells, leading to cell proliferation and activation, without stimulating the proliferation of immunosuppressive Treg cells.

ADSTILADRIN (Nadofaragene firadenovec-vncg)

FDA Approval: 2022

Gene therapy

ADSTILADRIN (Nadofaragene firadenovec-vncg) is a gene therapy leading to expression of interferon (IFN)α2b in uroepithelial cells. It is a nonreplicating adenoviral vector containing the cDNA for IFNα2b. Intravesical administration leads to prolonged (at least 7 days) expression of IFNα2b in tumor and uroepithelial cells. IFNα2b is believed to have pleiotropic effects including direct cytotoxic effects in tumor cells, antiangiogenic effects, and increased expression of tumor-associated antigens. It also modulates the immunologic properties of the tumor microenvironment, enhancing both innate and adaptive antitumor immunity.1

KEYTRUDA (Pembrolizumab)

FDA Approval: 2020

Targeted therapy

KEYTRUDA (pembrolizumab) is a programmed death receptor-1 (PD-1) blocking antibody. Some tumors express PD-1 ligands (PD-L 1 or PD-L 2) allowing them to bind PD-1 on T cells. This interaction inhibits T-cell proliferation and cytokine production, thereby inhibiting the T-cell response to tumor cells. Pembrolizumab (intravenous) blocks this interaction by binding to PD-1, thereby permitting the antitumor T-cell response.1

Intravesical BCG (Bacillus Calmette-Guérin) therapy

FDA Approval: 1976

Immunotherapy

Incompletely understood, but BCG is believed to trigger immune responses leading to cytotoxicity against bladder cancer cells.1

Surgery/Other

TURBT was introduced in the early 1900s, combining earlier innovations such as the direct-vision cystoscope and a resonator to generate monopolar current. More recent advances include bipolar electrocautery and enhanced cystoscopy, including fluorescence cystoscopy and narrow band imaging1.

  1. Kim LHC, Patel MI. Transurethral resection of bladder tumour (TURBT). Transl Androl Urol. 2020;9(6):3056-3072. doi: 10.21037/tau.2019.09.38