AstraZeneca’s Lung Cancer Pill Wins EU Approval

Three months after US regulators gave the treatment the green light, AstraZeneca’s new lung cancer pill, Tagrisso, has won early approval for use in the EU.

Tagrisso, also known by its clinical name osimertinib AZD9291, is one of six cancer medicines that AstraZeneca hopes will rebuild its sales after losing patent on older drugs.

The EC granted conditional marketing authorisation for Tagrisso to treat patients with a certain type of lung cancer that is particularly resistant to treatment.

Tagrisso is the first drug to be approved under the regulator’s accelerated access scheme, which fast tracks authorisation of drugs that are deemed to be either of major public interest or if there is unmet need.

AstraZeneca says Tagrisso could potentially generate revenues of $3bn a year.

Sean Bohen, chief medical officer at AstraZeneca, said: “The European Commission’s expedited approval reflects the importance of this innovative medicine for addressing the needs of patients with lung cancer who have the T790M mutation.

“We are now building on our understanding of the clinical activity of osimertinib to explore its full potential in patients with [this type of lung cancer] in multiple treatment settings.”

The regulatory consent makes Tagrisso the fastest development programme in the industry, having gone from human trials to approval in just over two years.

It is also an important milestone for the Anglo-Swedish pharmaceuticals giant, as it develops its portfolio of next-generation cancer medicines based on research into the genetic mutations that cause cancer and an understanding of what happens when resistance to certain treatments occurs.

AstraZeneca, which will report its full-year results on Thursday, believes it can increase investment in research and development without sacrificing profit growth.

The drugs giant has also been repositioning its portfolio to focus on key areas of strength, including oncology, in the face of falling revenues as some of its key drugs lose their patents.


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