FDA has approved the first drug for bladder cancer that harnesses the
body's immune system, the first major advance in three decades against
the most common type of bladder cancer.
Tecentriq won accelerated approval Wednesday from the
Food and Drug Administration for treating patients with advanced
urothelial cancer after chemotherapy stops helping them, a point when
most usually die within about six months.
Such conditional approval is granted based on
promising initial test results for disorders where patients have few or
no options. Testing on many more patients to confirm the early results,
which is required to obtain full approval from the FDA, is in progress.
Tecentriq, developed by the Roche Group's Genentech
unit, blocks a protein found on many tumor cells that deactivates
T-cells, the key immune-system cells that hunt down and destroy cancer
cells.
A similar drug from Bristol-Myers Squibb Co., Opdivo, was approved by
the FDA late Tuesday for treating Hodgkin lymphoma, the fourth cancer
type for which it's been approved in the U.S.
Both drugs are part of a promising new class of
injected cancer medicines that work with the patient's own immune
system, helping it find and kill tumor cells that might otherwise
multiply by using mechanisms to hide from immune-system sentinels.
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