With positive feedback from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), pharmaceutical company AstraZeneca's lung cancer therapy Tagrisso (AZD9291, osimertinib) will likely soon be available to European patients.
The oral, once-daily treatment is for adult lung cancer patients living with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC); whose disease worsened during or after therapy with an EGFR tyrosine kinase inhibitor (TKI); or patients with a T790M mutation who have not been treated with an EGFR-TKI.
"The CHMP’s recommendation for osimertinib to receive marketing approval is a positive step for patients in Europe," Sean Bohen, chief medical officer of AstraZeneca, said. "This follows the recent U.S. accelerated approval of osimertinib and its adoption in the U.K. under the Early Access to Medicines Scheme to meet urgent unmet need.
"Building on the breakthrough clinical evidence, we’re investigating osimertinib’s full potential as a monotherapy and in novel combinations with other precision medicines and immunotherapies from our comprehensive oncology pipeline," Bohen said.
Lung cancer is a major concern in Europe, killing 260,000 people each year, according to Jean-Charles Soria, head of the drug development department at the Gustave Roussy Cancer Center in Paris, France.
"There is an urgent need for new treatments," Soria said. "As a treating physician, it is very gratifying to see the progression of osimertinib towards use in clinical practice for patients living with EGFRm T790M non-small cell lung cancer."
More information about Tagrisso can be found online at www.astrazeneca.com.
