Osimertinib Tablets 40 mg, 80 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 40 mg, 80 mg

Reference Brands: Tagrisso (USA/EU)

Category: Oncology Cancer Care

Osimertinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer in patients who have certain types of abnormal epidermal growth factor (EGFR) genes.

Product Description:

Osimertinib is a third-generation EGFR inhibitor built to solve the problem that defeated the first generation. Tumours treated with gefitinib or erlotinib escape after about a year, most often by acquiring the T790M gatekeeper mutation, which blocks those drugs from binding. Osimertinib binds irreversibly and is active against T790M while sparing wild-type receptor, which is why it causes markedly less rash and diarrhoea than its predecessors despite greater potency.

It is now used first line in EGFR-mutant advanced non-small cell lung cancer rather than held in reserve, as adjuvant treatment after resection of EGFR-mutant disease, and after progression on earlier inhibitors in T790M-positive tumours. It penetrates the central nervous system well and controls brain metastases, a decisive advantage in this population. Diarrhoea, rash, paronychia and stomatitis are usually manageable; QT prolongation, reduced ejection fraction and rare interstitial lung disease need monitoring.

Sourcing notes. Originator product, on patent in the major markets, with two tablet strengths — the lower one exists for dose reduction, not as an alternative starting dose. EGFR mutation testing is mandatory at the destination. Oral solid, room temperature.