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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 clinical trial will evaluate Genprex's Reqorsa and AstraZeneca's Tagrisso in patients with EGFR-mutated non-small cell lung cancer.

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.

Roche's real-time PCR test detects defined mutations of the epidermal growth factor receptor gene in DNA from non-small cell lung cancer patients.

Researchers showed benefit from chemotherapy in patients classified as high risk by the test, independent of their EGFR mutation status.

The company submitted data from the ADAURA study, and the agency is slated to issue a decision on the application by the first quarter in 2021.

AstraZeneca's EGFR-inhibitor has now demonstrated an 'overwhelming' disease-free survival and CNS recurrence benefit, but overall survival benefit remains unknown.

NICE is reversing its earlier negative recommendation for the lung cancer drug after AstraZeneca agreed to provide it at a discount.

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.

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