Osimert 80 mg is a pharmaceutical product containing osimertinib, an oral EGFR tyrosine kinase inhibitor. It is intended for use in selected patients with non-small cell lung cancer whose tumors contain specified EGFR alterations.
Osimertinib does not work by broadly killing rapidly dividing cells in the same manner as conventional cytotoxic chemotherapy. Instead, it targets abnormal EGFR signaling involved in the growth and survival of certain cancer cells.
Product identity
| Attribute | Osimert 80 mg |
| Brand/product name | Osimert |
| Generic name | Osimertinib |
| Strength | 80 mg |
| Form | Tablet |
| Route | Oral |
| Pharmacologic class | EGFR tyrosine kinase inhibitor |
| Therapeutic area | Oncology |
| Manufacturer | Everest Pharmaceuticals Ltd. |
| Reference/originator brand | Tagrisso |
| Reference/originator company | AstraZeneca |
Everest’s official product catalogue identifies Osimert as Osimertinib INN 80 mg.
What is the active ingredient?
The active ingredient is osimertinib. The drug is administered as osimertinib mesilate in the reference product, while the clinically relevant active moiety is osimertinib. The EMA identifies osimertinib as the active substance of Tagrisso and classifies the medicine among protein kinase inhibitors.
Originator and reference product
Osimertinib was developed as AZD9291 and became associated with AstraZeneca’s Tagrisso brand. The first U.S. approval of Tagrisso was in 2015.
Tagrisso is therefore an important reference product when discussing the clinical development and regulatory history of osimertinib.
Osimert is a separate product manufactured by Everest Pharmaceuticals. The active ingredient relationship should not be confused with ownership or manufacturing identity.
What does osimertinib target?
Osimertinib targets mutant EGFR proteins, including common sensitizing alterations such as EGFR exon 19 deletions and exon 21 L858R, as well as the T790M resistance mutation. It binds irreversibly to its target through covalent interaction with the kinase domain.
Treatment context
Osimertinib is used within biomarker-directed oncology. Before treatment, healthcare professionals may use tumor tissue or validated molecular testing to establish relevant EGFR alterations. FDA-authorized companion diagnostic information specifically identifies EGFR exon 19 deletions, L858R and T790M in relation to osimertinib.
Limitations
Osimertinib is not a general treatment for every form of lung cancer. Its use depends on tumor biology, disease stage, previous therapy and the approved indication in the relevant jurisdiction.