The agency made its decision based on data showing adjuvant Tagrisso decreased the risk of cancer recurrence or death by 80 percent compared to placebo.
The Phase I/II trials will study Reqorsa in combination with Merck's Keytruda and AstraZeneca's Tagrisso in certain molecularly defined lung cancer subgroups.
AstraZeneca's EGFR-inhibitor has now demonstrated an 'overwhelming' disease-free survival and CNS recurrence benefit, but overall survival benefit remains unknown.
The final GioTag data suggests a survival benefit with the regimen among patients with EGFR-mutant NSCLC harboring acquired T790M resistance mutations.
The agency approved the test for use across solid tumors and with multiple companion diagnostic indications including one for prostate cancer and three for lung cancer.
