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 The approval, while expected, marks a milestone for the British
company, which expects new cancer drugs to help revive its fortunes
following patent losses on older blockbuster products like
cholesterol pill Crestor and Nexium for heartburn.
Bladder cancer itself is a relatively small initial market, where
AstraZeneca is lagging behind rivals Bristol-Myers Squibb and Roche
whose immunotherapies are already approved for the condition.
Durvalumab's big commercial opportunity lies in previously untreated
lung cancer, where key clinical trial results, including with
combination therapy, are due in June or July.
Leerink analyst Seamus Fernandez sees durvalumab capturing a modest
10 percent of the estimated $2.3 billion global bladder cancer
market, while AstraZeneca in 2014 put the drug's peak sales in all
cancers at $6.5 billion, including combination use.
The U.S. Food and Drug Administration (FDA) said late on Monday it
granted accelerated approval to AstraZeneca's drug to treat advanced
bladder cancer in patients whose disease had progressed despite
chemotherapy.
The drug, which will have the brand name Imfinzi, works by helping
the body's immune cells kill cancer, offering an alternative to
toxic chemotherapy. While not without side effects, such immuno-oncology
treatment has the potential of longer-lasting efficacy, although it
comes at a high price.
AstraZeneca said the average wholesale acquisition cost of
durvalumab would be around $15,000 a month.
"This first approval for Imfinzi is an important milestone in our
return to growth," said AstraZeneca Chief Executive Pascal Soriot.
The drug belongs to a new class of medicines called PD-L1 inhibitors
that block a mechanism tumors use to evade detection from the immune
system.
It was approved by the FDA for use in patients with locally advanced
or metastatic urothelial carcinoma, by far the most common form of
bladder cancer, regardless of their status for the amount of PD-L1
protein on their cancer cells.
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Durvalumab won accelerated approval, which enables the use of
therapies for serious conditions to fill an unmet medical need based
on data the FDA believes is likely to predict a clinical benefit.
AstraZeneca is required to conduct trials to confirm actual benefit
to patients.
The FDA also approved a complementary diagnostic from Roche that can
be used with the drug to assess PD-L1 levels. Studies have shown
patients with high PD-L1 are more likely to do well on durvalumab,
although such a test is not required for its use.
Durvalumab is being tested on its own and also in combination with
another immune system-boosting therapy called tremelimumab in
various cancers.
The medicine is the latest immunotherapy to be approved by the FDA,
after nods for treatments developed against various cancers by
Bristol-Myers Squibb, Merck & Co, Roche, and a collaboration between
Germany's Merck KGaA and Pfizer.
AstraZeneca shares were up 0.3 percent in early London trading on
Tuesday.
(Editing by Susan Thomas and Jason Neely)
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