(Adds details, shares)
May 1 The U.S. Food and Drug Administration on
Monday granted accelerated approval to AstraZeneca Plc's
immuno-oncology drug to treat a type of bladder cancer
in patients whose disease progressed despite chemotherapy.
The drug, called Imfinzi, works by helping the body's immune
cells kill cancer, offering an alternative to toxic
While not without side effects, immuno-oncology is a kinder
option that also promises longer-lasting efficacy, although it
Imfinzi, chemically known as durvalumab, belongs to a new
class of oncology drugs called PD-L1 inhibitors that block a
mechanism tumors use to evade detection from the immune system.
The drug was approved on Monday for use in patients with
locally advanced or metastatic urothelial carcinoma.
The drug won accelerated approval, which enables the use of
therapies for serious conditions to fill an unmet medical need
based on data the agency believes is likely to predict a
clinical benefit. AstraZeneca is required to conduct trials to
confirm actual benefit to patients. (bit.ly/2oYipOi)
The FDA also approved a complementary diagnostic from Roche
Holding AG to assess whether the PD-L1 protein is
expressed in urothelial carcinoma tissue.
Imfinzi, considered one of AstraZeneca's most important
pipeline drug, is being tested on its own and also in
combination with another immune system-boosting therapy called
tremelimumab in various cancers, including lung cancer.
U.S. listed shares of the company were up marginally at
$30.47 in afternoon trading.
(Reporting by Divya Grover in Bengaluru; Editing by Supriya