Osimertinib 80 mg is an oral tablet containing 80 mg of osimertinib, an EGFR tyrosine kinase inhibitor used for selected EGFR-mutated NSCLC. It is a targeted treatment rather than a conventional cytotoxic chemotherapy medicine.
Product identity
| Attribute | Information |
|---|---|
| Generic name | Osimertinib |
| Common salt | Osimertinib mesilate/mesylate |
| Strength | 80 mg |
| Dosage form | Tablet |
| Administration | Oral |
| Pharmacologic class | EGFR tyrosine kinase inhibitor |
| Reference product | Tagrisso |
| Reference company | AstraZeneca |
| Common generic brands | Tagrix, Osicent, Osimert |
| Patient population | Selected patients with EGFR-mutated NSCLC |
Tagrisso is the established reference product. DailyMed identifies AstraZeneca Pharmaceuticals LP as the U.S. packager and records an initial U.S. approval in 2015.
Originator and generic relationship
A generic product containing osimertinib has the same active pharmaceutical ingredient but may differ from Tagrisso in manufacturer, excipients, packaging, authorization pathway and commercial presentation.
Therefore, “contains osimertinib” and “is Tagrisso” are not interchangeable statements.
What does 80 mg mean?
The 80 mg designation describes the amount of osimertinib represented in the dosage unit. Current U.S. labeling recommends 80 mg once daily for the approved treatment settings described in the label.
Who should determine treatment?
Osimertinib is prescription cancer therapy. The appropriate treatment depends on tumor genetics, disease stage, previous therapy, organ function, other medicines and the applicable regulatory indication.