Home Front Page AstraZeneca’s lung cancer drug, Tagrisso, gets FDA approval

AstraZeneca’s lung cancer drug, Tagrisso, gets FDA approval

AstraZeneca's new kung cancer drug, Tagrisso, made for patients whose condition worsen after treatment using other therapies, was granted timely approval by the FDA this Friday

Tagrisso, a lung cancer drug called AZD9291, has raided the hopes of its maker AstraZeneca to help bolster its sales after the company lost patents on older drugs. Tagrisso is a lung cancer treatment by AstraZeneca, specifically developed for patients whose condition became worse post treatment using other kinds of therapies. The drug was granted a surprisingly timely approval by the FDA this Friday.

The U.S. Food and Drug Administration (FDA) has given its approval to a tablet once used for the treatment of a sub-set of patients who had advanced non-small cell lung cancer much earlier than expected by experts.

According to Thomson Reuters Cortellis, analysts from the industry are cautious regarding its sales during the coming few years, keeping in mind the consensus expectations, which are projecting sales of $1.1 billion in 2020.

After Pfizer attempted a takeover last year, AstraZeneca defended itself by forecasting that the drug could sell as much as $3 billion per year.

AstraZeneca spokesperson stated that it would make Tagrisso accessible to U.S. patients who are eligible for the same in the shortest possible time and its price would be “comparable to other oral cancer therapies”.

Similar to another competing drug that is being developed at Clovis Oncology, Tagrisso focuses a typical kind of genetic mutation, called T790M, which helps tumors avoid current lung cancer pills.

A companion diagnostic test for use with Tagrisso, made by Roche, has also been developed by the FDA to detect this mutation.

FDA has given its approval to Tagrisso unusually fast and it took just slightly more than 2-1/2 years from the beginning of clinical trials to approval in the world’s top drugs market. That speed reflects a speedy route to the approval process at the FDA and AstraZeneca’s willpower to back better drugs as fast as possible.

Eric Criscuolo, who is a Mizuho Securities analyst, stated that the speedy FDA decision suggested a similarly fast approval of Clovis’ rival drug rociletinib,whereas its official date is around the last week of March.

When Pfizer tried to launch a takeover last year, Chief Executive Pascal Soriot had cautioned that the new cancer drug’s progress could be disturbed and even delayed by this distraction of a mega-merger.

After the approval of its new cancer drug the shares of AstraZeneca stepped up by 0.5 percent in a weaker European stock market, whereas the shares of Clovis were up by 1 percent on Nasdaq.

Source: Reuters