ImmunityBio’s ANKTIVA wins EMA nod for early EU approval in hard-to-treat bladder cancer

FDA nod to groundbreaking bladder cancer combo therapy for surgery patients

Call it a major milestone in bladder cancer therapy that aims to provide a lifeline for patients who previously had limited options

FDA approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients

The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy

Relmada gains FDA backing for two registrational trials and reports 92% response with NDV-01 in bladder Cancer

Relmada expects to initiate its Phase 3 program in the first half of 2026

FDA grants priority review to Merck’s KEYTRUDA and KEYTRUDA QLEX combos with Padcev for muscle-invasive bladder cancer

The submissions are supported by data from the Phase 3 KEYNOTE-905 trial

AstraZeneca’s Imfinzi cuts death risk by 32% in high-risk non-muscle-invasive bladder cancer

Adding one year of Imfinzi treatment to Bacillus Calmette-Guérin (BCG) induction and maintenance therapy delivered an early and sustained disease-free survival benefit vs. BCG alone

Imfinzi approved in the EU as first and only perioperative immunotherapy for muscle-invasive bladder cancer

Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone

Imfinzi perioperative regimen improved survival across muscle-invasive bladder cancer patients

Imfinzi reduced the risk of distant metastases and death from bladder cancer vs. neoadjuvant chemotherapy alone

Pfizer’s Sasanlimab in combination with BCG improves survival in patients with bladder cancer

If approved, sasanlimab would be the first PD-1 inhibitor, in combination with BCG, to significantly prolong event-free survival in this patient population

Imfinzi improved event-free survival and overall survival for bladder cancer

First immunotherapy regimen before and after surgery to extend survival in bladder cancer