AstraZeneca Wins European Approval for Lung Cancer Drug Tagrisso -- Update
February 03 2016 - 4:56AM
Dow Jones News
By Denise Roland
AstraZeneca on Wednesday said European regulators have approved
a potential blockbuster lung cancer drug that the company hopes
will form a key plank of its growth plans.
The company believes the drug, called Tagrisso, could generate
as much as $3 billion a year in sales, potentially helping it
achieve its ambition to increase overall revenue to $45 billion by
2023, compared with about $26 billion in 2014. However, analysts
have been more cautious about the drug's potential, with Citi's
Andrew Baum forecasting sales of $1 billion by 2020.
Tagrisso is the first drug to target a subset of patients whose
tumors have spread and developed a normally treatment-resistant
mutation called T790M.
AstraZeneca said Tagrisso was the first new drug to win
accelerated approval by the European Medicines Agency. The decision
comes two months after Tagrisso was given the green light by the
U.S. Food and Drug Administration.
The drug entered its first human trial in 2013, and has sped
through development. It was submitted to regulators based on the
results of two "phase two," or mid-stage studies, on a total of 474
patients. Those studies showed the drug shrunk tumors in 66% of
cases.
Normally, companies must run larger so-called phase-three trials
before they can submit a drug to regulators. AstraZeneca is also
running a continuing phase-three clinical trials on Tagrisso to
gather more data on the drug's safety and effectiveness.
Lung cancer is one of the deadliest forms of the disease. Nearly
354,000 people in Europe died from lung cancer in 2012, according
to Cancer Research UK, a research charity. The majority of patients
have a form of the disease known as non-small cell lung cancer, of
which around 10% develop a mutation in a gene known as EGFR. Of
those patients, around two-thirds go on to develop the T790M
mutation during treatment.
Sean Bohen, head of medicines development at AstraZeneca, said
the fast approval "reflects the importance of this innovative
medicine for addressing the needs of patients with lung cancer who
have the T790M mutation."
Write to Denise Roland at Denise.Roland@wsj.com
(END) Dow Jones Newswires
February 03, 2016 04:41 ET (09:41 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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