AstraZeneca: priority review in the USA for Tagrisso

(CercleFinance.com) - AstraZeneca announced on Monday that the US FDA has granted priority review to its anti-cancer drug Tagrisso for the treatment of a particular form of bronchial cancer.


This is stage 3 non-small cell lung cancer in patients with a mutation in the EGFR gene, after chemotherapy.

If approved, Tagrisso would be offered to patients with a deletion in exon 19 or an L858R mutation in exon 21.

In a press release, AstraZeneca points out that nearly 200,000 Americans are affected by lung cancer every year, 80% to 85% of them by so-called non-small cell lung cancer, the most common form of the disease.

Of these, 15% have EGFR mutations and one in five has a non-operable form, adds the laboratory.

A 'priority review' means that the FDA aims to rule on an application for approval over a shorter period than standard procedures, generally around six months.


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