AstraZeneca's Tagrisso gains FDA approval

(Sharecast News) - Drugmaker AstraZeneca traded higher early on Monday after revealing that a combination of its cancer drug Tagrisso with chemotherapy had gained US approval to treat a particular type of lung cancer. AstraZeneca said Tagrisso had been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.

The FTSE 100-listed group stated the approval followed a priority review by the Food and Drug Administration and was based on the results from its FLAURA2 Phase III trial.

"Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy which is the first-line global standard of care," said AZN. "Median progression-free survival by investigator assessment was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement versus Tagrisso monotherapy (16.7 months)."

AstraZeneca added that as part of its "ongoing commitment to treating patients as early as possible in lung cancer", Tagrisso was also being investigated in the neoadjuvant setting in its NeoADAURA Phase III trial, with results expected later this year, and in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

As of 0920 GMT, AstraZeneca shares were up 3.05% at 10,402.0p.

Reporting by Iain Gilbert at Sharecast.com