Osimertinib (previously known as mereletinib or AZD9291; trade name Tagrisso) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) drug developed by AstraZeneca Pharmaceuticals – for mutated EGFR cancers.
Medical uses
Osimertinib is used to treat locally advanced or metastatic non-small-cell lung cancer (NSCLC), when the cancer has the specific T790M mutation in the gene coding for epidermal growth factor receptor. In the US the mutation must be detected with an FDA-approved companion diagnostic test, and the person must have been stopped responding to the other EGFR-inhibitors.
The NSCLC in people receiving the drug has developed resistance mutations, namely C797S occurs in EGFR exon 20 or amplifications of the EGFR gene, even as T790M clones have been eliminated.
It causes fetal harm, so should not be used in women who are pregnant, and women who take it should avoid becoming pregnant.
Caution should be taken in people with a history of interstitial lung disease (ILD) were excluded from clinical trials, as the drug can cause severe ILD or pneumonia. Caution should also be taken in people with a predisposition to long QT syndrome as the drug can provoke this.
Osimertinib
Product Description
Product information:
| Items | Requirements |
| Appearance | White or off-white crystalline powder |
| Identification | Meets the requirements |
| Bacterial Endotoxins | Not more than 0.125EU/mg |
| Loss on drying | ≤5% |
| Heavy metals | ≤20ppm |
| Assay(on the dried basis) | 99% min |
Specification
| Item | Specification |
| Specific rotation | +39.5 to +41.5° |
| State of solution(transmittance) | Clear 98.0% min. |
| Chloride[cl] | 0.020% max. |
| Ammonium [NH4] | 0.02% max. |
| Sulfate[SO4] | 0.020% max |
| Iron[Fe] | 10ppm max. |
| Heavy metals [Pb] | 10ppm max |
| Arsenic[As2O3] | 1ppm max |
| Other amino acids | Chromatographically not detectable |
| Loss on drying | 0.20% max. |
| Residue on ignition[sulfated] | 0.10% max. |
| Assay | 99.0% min |
Packaging & Shipping:
(1)1kg/bag (1kg net weight, 1.2kg gross weight, packed in an aluminum foil bag; Inner: double-layer PE)
(2)5kg/bag (5kg net weight, 5.2kg gross weight, packed in an aluminum foil bag; Inner: double-layer PE)
(3)10kg/drum (10kg net weight, 12kg gross weight; Packed in a cardboard-drum with two plastic-bags inside; Drum Size: 310mm high, 400mm diameter)
(4)25kg/drum (25kg net weight, 28kg gross weight; Packed in a cardboard-drum with two plastic-bags inside; Drum Size: 510mm high, 350mm diameter)
Shipment method: By courier, by air or by sea
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