Name | AZD-9291 |
CAS number | 1421373-65-0 |
Description | AZD-9291, known generically as Osimertinib, is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) specifically designed to target both EGFR-sensitizing mutations and the T790M resistance mutation. |
Structural formula |  |
Molecular Formula | C28H33N7O2 |
Molecular Weight | 499.61 g/mol |
Appearance | White powder |
Quality Standard | 99% |
Storage Condition | Cool dry place( away from the light) |
Shelf Life | >2 years if stored properly |
Sample package | Aluminium foil bag |
Commercial package | Aluminium Tin, Fiber drum |
Origin | China |
AZD-9291, known generically as Osimertinib, is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) specifically designed to target both EGFR-sensitizing mutations and the T790M resistance mutation. Developed through structure-based drug design, this compound features an acrylamide group that enables covalent binding to cysteine-797 residue in the ATP-binding site of EGFR mutants. Its molecular architecture was engineered to spare wild-type EGFR, thereby reducing off-target effects that limited earlier EGFR inhibitors. The compound represents a significant advancement in targeted cancer therapy, addressing one of the most challenging resistance mechanisms that emerges during treatment with first- and second-generation EGFR TKIs.
Uses and Applications
The primary application of osimertinib is in the treatment of non-small cell lung cancer (NSCLC) harboring specific EGFR mutations. It is approved for first-line treatment of metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, and for patients with EGFR T790M mutation-positive NSCLC who have progressed on prior EGFR TKI therapy. The medication is administered orally in tablet form, typically once daily, and demonstrates excellent central nervous system penetration, making it effective for managing brain metastases. Clinical use is guided by companion diagnostic tests that identify eligible patients based on their EGFR mutation status, representing a paradigm of precision oncology.
Application Market
The market for osimertinib is substantial within the oncology pharmaceutical sector, positioned as a premium-priced targeted therapy for NSCLC. As a patented drug marketed under the brand name Tagrisso®, it generates significant revenue globally, though it faces impending patent expiration in various markets. Distribution is tightly controlled through specialty pharmacies and hospital networks, with access often managed through insurance coverage and patient assistance programs. The market is truly global, with strong penetration in North America, Europe, and Asia, particularly in regions with high incidence of EGFR-mutant lung cancer. Companion diagnostic testing represents an adjacent market that is essential for appropriate patient identification and treatment.
Important Considerations
Clinical use of osimertinib requires careful management of several characteristic adverse effects. Common side effects include diarrhea, skin reactions (dry skin, pruritus, stomatitis), and paronychia, which are generally manageable with supportive care. More serious risks include QT interval prolongation, cardiomyopathy, and interstitial lung disease/pneumonitis, necessitating regular monitoring through electrocardiograms, echocardiograms, and assessment of pulmonary symptoms. Important drug interactions occur with strong CYP3A4 inducers and medications that prolong QT interval. Appropriate dosing adjustments are necessary for patients with severe hepatic impairment. Patients should be educated about reporting symptoms of lung inflammation (cough, dyspnea, fever) immediately. Access to the medication typically requires confirmation of EGFR mutation status through validated diagnostic testing.
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