AstraZeneone's new adaptation application was reviewed by the FDA on a priority note

AstraZeneone announced that osimertinib (Tagrisso) new indications (sNDA) has been approved by the FDA for priority review, PDUFA action date is the first quarter of 2021, the new indications for the treatment of early (IB, II and IIIA) skin growth factor mutants (EGFRm) non-small cell lung cancer (NSCLC) patients after the removal of root-based tumors.
press release that stunning results from phase 3 clinical trial ADAURA showed that Oghidini's treatment reduced the risk of recurrence or death by 80 percent.
Although up to 30% of patients with non-small cell lung cancer can be diagnosed early for potential root-and-treat surgery, recurrence is still common in early-stage diseases, with nearly half diagnosed as IB-phase NSCLC patients and more than three-quarters diagnosed as IIIA-phase NSCLC patients experiencing recurrence within five years.
This sNDA is based on the results of phase 3 clinical ADAURA trials, which showed improvements in disease-free survival (DFS) statistics and clinical significance in the primary analytical population of EGFRm NSCLC patients in Phase II and IIIA, as well as in the overall trial population of IB-IIIA phase NSCLC patients.
April 2020, the Independent Data Monitoring Board recommended that the trial be revealed two years in advance, based on the overwhelming efficacy of Oghidini in the postoperative assisted therapy trial for lung cancer (ADAURA).
researchers and patients continued to participate in the trial and remain blind to treatment; the results of the ADAURA trial were published in May at the annual meeting of the American Society of Clinical Oncology and recently published in the New England Journal of Medicine; and in July, Osimertinib, Tagrisso was recognized as a breakthrough therapy (BTD) in the United States.
is a third-generation, irreversible EGFR-TKI with clinical activity against central nervous system metastasis.
approved in the United States, Japan, China, the European Union and many other countries around the world for first-line treatment of localized advanced or metastasis EGFRm NSCLC patients.
it is worth mentioning that last week, the drug was included in the proposed priority review by china's National Drug Administration (NMPA) for complementary postoperative treatment of tumors in adult patients with EGFR-sensitive mutations.