Back in September, AstraZeneca’s Tagrisso posted data showing it could outdo the competition in treating first-line, EGFR mutation-bearing lung cancer patients. And now, the FDA is helping the drug speed toward an approval in that population.
Tagrisso has picked up the agency’s priority review tag, AstraZeneca said on Thursday, based on results from the British company’s phase 3 Flaura trial. Those results showed Tagrisso could cut the risk of disease progression or death in first-line, EGFR patients by 54% compared with standard-of-care products Tarceva from Roche and Iressa from AstraZeneca.
In a performance that later spurred guideline changes from the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology, Tagrisso also staved off disease progression for a median 18.9 months, versus 10.2 months for the standard-of-care therapies.
A first-line nod would mean big things for Tagrisso, whose patient pool is currently limited to those with an abnormal T790M gene who have failed on other treatments.
And big things are exactly what AZ has predicted for the treatment. With questions still swirling around its immuno-oncology combo of Imfinzi and candidate tremelimumab, it’s sought to turn Wall Street’s attention to the product, talking up a $3 billion sales target. Earlier this year, company R&D chief Sean Bohen, M.D., Ph.D., joked with analysts that Tagrisso “has been overshadowed” by its immuno-oncology brethren.
Elsewhere in AstraZeneca’s cancer portfolio, new approval Calquence is working to take some of the burden off I-O, too. Earlier this month at the American Society of Hematology annual meeting in Atlanta, the company touted results showing the newcomer could provoke an overall response rate of 81% and a complete response rate of 40% in mantle cell lymphoma patients.