AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

 AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

AstraZeneca Reports the US FDA Acceptance of sBLA and Granted Priority Review for Imfinzi (durvalumab) to Treat Patients with Extensive-Stage Small Cell Lung Cancer

Shots:

  • The BT designation is based on P-III ADAURA trial which involves assessing Tagrisso (80 mg) vs PBO in 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated across 20 centers and 200+ countries including the US, EU, South America, Asia, and the Middle East
  • The study resulted in improvement in DFS, reduction in risk of disease recurrence, or death by 79% in the adjuvant treatment of Stage IB-IIIA EGFRm NSCLC patients, also presented at ASCO 2020. Additionally, the trial will continue to assess OS
  • Tagrisso (osimertinib) is third-generation, irreversible EGFR-TKI once-daily oral tablets approved 1st-line EGFRm advanced NSCLC and EGFR T790M mutation-positive advanced NSCLC in the US, Japan, China, the EU

Click here to read full press release/ article | Ref: AstraZeneca | Image: Behance

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

Related post