AZ’s Tagrisso continues successes with EU approval
pharmafile | April 26, 2017 | News story | Research and Development, Sales and Marketing | AstraZeneca, EU, European Commission, NSCLC, Tagrisso
More good news for AstraZeneca’s Tagrisso (osimertinib), as the company announces that the European Commission has granted the drug full marketing authorisation for the treatment of locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) in adult patients.
The drug made headlines last month when it became the first therapy to be approved under China’s new Priority Review Pathway. It was greenlighted for the same indication in that instance, and days later was also approved by the FDA for marketing authorisation in the US.
This new decision was based upon Phase 3 trial results involving 419 participants, which showed that Tagrisso significantly boosted progression-free survival rates to 10.1 months, compared to 4.4 months with standard platinum-based doublet chemotherapy. Objective response rate was also improved to 71% compared to 31%.
“The full approval of Tagrisso in the EU is further evidence of our exciting progress in transforming the science of cancer care to deliver life-changing medicines to people most in need,” commented Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca. “Having demonstrated its superiority over chemotherapy in EGFR T790M mutation-positive non-small cell lung cancer, Tagrisso has the potential to become the new standard of care for patients with this difficult-to-treat form of lung cancer.”
Matt Fellows
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