Home Alzheimer’s Disease AstraZeneca Withdraws Durvalumab Indication for Previously Treated Locally Advanced or Metastatic Bladder...

AstraZeneca Withdraws Durvalumab Indication for Previously Treated Locally Advanced or Metastatic Bladder Cancer

AstraZeneca announced it has voluntarily withdrawn the indication for durvalumab (Imfinzi) in previously treated adult patients with locally advanced or metastatic bladder cancer in the United States.1

Health care providers are currently being notified of this update and patients with metastatic bladder cancer being treated with durvalumab should consult with their individual provider regarding their care moving forward.

Importantly, this decision was made in consultation with the FDA and the withdrawal is aligned with FDA guidance for evaluating indications with accelerated approvals that did not meet post-marketing requirements, as part of a broader industry-wide evaluation. However, this withdrawal does not affect indications outside the United States and does not impact other approved indications for durvalumab within or outside the United States.

“The science of immunotherapy…

Continue Reading to the Source


Please enter your comment!
Please enter your name here

Most Popular

Lower-Dose Hypofractionated Radiotherapy Schedule Proves Effective for Patients With Locally Advanced Bladder Cancer

Using a hypofractionated schedule of 55 Gy in 20 fractions over 4 weeks to treat patients with locally advanced bladder cancer was noninferior to...

Study Identifies New Biomarker Which Could Predict Response to CD40 Immunotherapy in Pancreatic Cancer

Research published in JCI Insight identified systemic inflammation as a possible resistance mechanism to a CD40–based chemoimmunotherapy in patients with advanced pancreatic cancer.1According to...

Significant Interfacility Variation Found in Implementation of Low-Value Breast Cancer Procedures

A number of facility-level characteristics were associated with the use of low-value breast cancer procedures, and interfacility variation presented an opportunity for formal de-implementation...

KarMMa Trial Results for Ide-Cel in Refractory Myeloma Show Favorable Efficacy

Chimeric antigen receptor (CAR) T-cell therapy with idecabtagene vicleucel (ide-cel) induced responses in almost 75% of patients with multiple myeloma following relpase on multiple...

Recent Comments