Wednesday, October 23, 2019 09:07 AM

HOW HAS FDA LABEL CHANGE AFFECTED TREATMENT OF ADVANCED BLADDER CA? - UROLOGY TIMES

Access to novel therapies early in the regulatory process as a result of the FDAs accelerated approval program can be valuable for many cancer patients, but the clinicians who are responsible for their care must have heightened vigilance for incoming data and FDA guidance about these drugs that have not gone through the gold standard of phase III testing.

Findings from a study investigating treatment utilization for advanced bladder cancer patients indicate that physicians are doing a pretty good job of responding to incoming safety data, said Ravi Parikh, MD, MPP, lead author of the recently published data (JAMA[1] 2019; 322:1209-11).[2]

The study analyzed changes in rates of immunotherapy and chemotherapy use following the FDA label change in the approved indications for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) that limited their use as first-line agents for treatment of advanced bladder cancer in cisplatin-ineligible patients to those with programmed death-ligand 1 (PD-L1) positive tumors. The two immunotherapy agents were originally approved through the accelerated approval program to be used as first-line treatment of any cisplatin-ineligible patients. The change, which was made in ...

News source: GOOGLE NEWS

See also: The Robotic Urologist