AstraZeneca Wins FDA Approval for Cancer Drug

A new drug for cancer from AstraZeneca that is designed for lung cancer sufferers whose cancer has worsened following treatments with other forms of therapy, won an early approval in the U.S. Friday, which is a big boost for the drug maker based in Britain.

Tagrisso, which is also referred to as AZD9291, is one of a number of cancer treatments AstraZeneca is counting on to rebuild sales following losses of patent protection on its older drugs.

During its defense against a hostile takeover attempt from U.S. based Pfizer in 2014, the drug maker forecast that this drug would eventually sell up to $3 billion annually.

Industry analysts are extra cautious about its sales over the upcoming years, with the consensus expecting revenue to reach $1.1 annually by 2020.

The United States Food and Drug Administration granted its approval for the tablet, which is taken once per day to treat a group of patients with non-small cell cancer of the lungs that is advanced. The approval by the FDA came earlier than was expected by analysts, as the official date for a decision was not until February of 2016.

An AstraZeneca spokesperson said the drug maker would make the newly approved Tagrisso available to patients who are eligible in the U.S. as quickly as possible and that its prices would be similar to the other cancer therapies that are taken orally.

Similar to a rival product currently in development by Clovis Oncology, Tagrisso targets T790M a genetic mutation that helps cancer tumors evade current pills taken for lung cancer.

The FDA approved a companion diagnostic test that is used with the new drug Tagrisso that is made by Swiss drug maker Roche to detect the mutation.

The path of Tagrisso to market has been exceptionally fast, taking only 2.5 years from the beginning of its clinical trials to its approval by the FDA for the world’s largest drug market.

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