BioPharmaPT
โ† All oncology drugs

Bladder & urothelial cancer

Oncologyยท 7 reviewed drugsยท 7721 cited findings behind them

What the regulatory reviews cover

This library contains regulatory review documents for several drugs indicated for bladder and urothelial cancer. These include Padcev, Tecentriq, Bavencio, Adstiladrin, Balversa, Javlor, and Imfinzi. The reported outcomes vary by drug and trial design.

For instance, Padcev showed an Objective Response Rate (ORR) of 32.2. Bavencio demonstrated a Median overall survival (avelumab) of 21.4 compared to 14.3 for the comparator arm, representing a 31% Reduction in risk of death. Adstiladrin reported an Incidence of Complete Response (CR) at any time of 53.4. Balversa had an Objective Response Rate (CR + PR) of 45.6 compared to 11.5 for Chemotherapy. Javlor showed a Median OS (VFL+CAPE arm) of 13.9 versus 11.7 for the CAPE arm. It is important to note that these figures are derived from different studies and are not directly comparable head-to-head.

The drugs โ€” one cited result each

Padcev

Astellas Pharma Inc.

Objective Response Rate (ORR): 32.2

Astellas Pharma Inc. โ€” Padcev FDA Review (BLA761137, ORIG 1,, p.24

Tecentriq

Roche Holding AG

Confirmed ORR (all patients): 14.8%

GENENTECH INC โ€” Tecentriq FDA Summary Review (NDA/BLA 761034, p.4

Bavencio

Merck B V

Median overall survival (avelumab): 21.4

EMD SERONO INC โ€” Bavencio FDA Review (NDA/BLA 761049, 2020), p.107

Adstiladrin

Ferring A S

Incidence of Complete Response (CR) at any time: 53.4

Ferring A S โ€” Adstiladrin EMA EPAR public assessment report, p.73

Balversa

Johnson & Johnson

Objective Response Rate (CR + PR): 45.6

EMA EPAR, p.115

Javlor

Pierre Fabre Medicament

Median OS (VFL+CAPE arm): 13.9

Pierre Fabre Medicament โ€” Javlor EMA EPAR variation assessme, p.29

Imfinzi

AstraZeneca PLC

ORR in overall study population (excluding 10 patients): 16.9

AstraZeneca PLC โ€” Imfinzi FDA Review (BLA761069, ORIG 1, 201, p.42

Different drugs were studied in different trials โ€” these figures are not head-to-head comparisons.

Explore the full evidence

Every finding behind these drugs โ€” searchable, comparable and answerable in plain language โ€” is in the Oncology research library โ†’

Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only โ€” not medical or investment advice.

Bladder & urothelial cancer โ€” 7 Drugs, FDA & EMA Review Findings | BioPharmaPT Oncology