The future may still be uncertain for AstraZeneca’s Imfinzi in first-line lung cancer, but the company has picked up an approval in that setting for fellow portfolio med Tagrisso.
The FDA OK'd the product Thursday for patients with EGFR mutations, basing its decision on phase 3 data that rolled out in September at the European Society for Medical Oncology annual meeting. There, AZ showed Tagrisso could slash the risk of disease progression or death by 54% when facing off against standard-of-care tyrosine kinase inhibitors Tarceva from Roche and Iressa from AstraZeneca itself.
Tagrisso also staved off cancer progression for a median 18.9 months, compared with 10.2 months for the standard-of-care meds.
Those results in December helped the British drugmaker win the agency’s priority review tag, which sped up Tagrisso’s trip down the regulatory pathway.
Now, Tagrisso’s patient pool will widen well beyond its previous restrictions, which limited its use to patients with an abnormal T790M gene who had failed on other therapies. And with those boundaries out the window, AZ’s executives think they can hit a $3 billion sales target with the drug.
The company, which is working hard turn things around after a tough fall off the patent cliff, is hoping that’s the case—especially because it’s still unclear whether its immuno-oncology combo of Imfinzi and CTLA4 candidate tremelimumab will have a place in the first-line non-small cell lung cancer landscape. So far, the pairing's trial data has come up short, though AZ has encouraged investors to wait for overall survival results before drawing any conclusions.
Even if the regimen does deliver data showing it can extend patients' lives, however, it’ll have to vie with Merck’s formidable Keytruda-chemo combo in the marketplace, and that cocktail has already shown it can improve survival significantly. Bristol-Myers Squibb, which recently touted positive early news for its own PD-1/PD-L1-CTLA4 duo, could give AstraZeneca a run for its money, too.