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The US FDA approved AstraZeneca's new drug Tagrisso (Osimertinib), formerly known as AZD9291, as the third generation of TKI targeted drugs for the treatment of advanced non-small cell lung cancer (NSCLC). This approval brought significant survival benefits to lung cancer patients, specifically those with EGFR T790M mutations — a resistance mutation that develops after treatment with earlier-generation EGFR inhibitors.
Tagrisso is an oral small molecule third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that can simultaneously address EGFR gene mutations including those at positions 18, 19, and 21, as well as acquired resistance through the T790M mutation. The drug received accelerated FDA approval on November 13, 2015, along with breakthrough therapy designation, priority review eligibility, and orphan drug designation — reflecting the seriousness of the condition it treats and the significant improvement it offers over existing treatments.
Tagrisso's safety and effectiveness were confirmed by two multi-center, single-arm studies involving 411 advanced NSCLC patients with positive EGFR T790M mutations who had worsened after receiving EGFR blockers. After receiving Tagrisso, 57% of patients in the first study and 61% in the second achieved complete tumor elimination or partial shrinkage. Alongside the drug approval, the FDA also approved the cobas EGFR Mutation Test v2 — the first companion diagnostic test capable of detecting the T790M resistance mutation — making treatment selection more precise and effective.
The most common side effects of Tagrisso include diarrhea, dry skin, rashes, nail infections, and redness, while more serious but uncommon side effects may include lung inflammation and heart damage. Experts from the Global Oncology Medical Network caution that Tagrisso is only targeted at NSCLC patients with EGFR mutations and is not a first-choice treatment for all lung cancer patients. Treatment must always follow a doctor's recommendations, and patients should not seek this drug abroad without proper medical guidance.
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About Dr. Nishant Mittal
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. Significant contributions to stem cell biology, developmental biology, and innovative research techniques mark his career. Research Highlights Dr. Mittal's research has focused on several key areas: 1) Cardio…
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