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Osimertinib
Osimertinib, sold under the brand name Tagrisso, is a medication used to treat non-small-cell lung carcinomas with specific mutations. It is a third-generation epidermal growth factor receptor tyrosine kinase inhibitor.
The most common side effects include diarrhea, rash, musculoskeletal pain, dry skin, skin inflammation around nails, sore mouth, fatigue, and cough.
Osimertinib was approved for medical use in the United States in November 2015, and in the European Union in February 2016.
Osimertinib is used to treat locally advanced or metastatic non-small-cell lung cancer (NSCLC), if the cancer cells are positive for the T790M mutation in the gene coding for EGFR or for activating EGFR mutations. The T790M mutation may be de novo or acquired following first-line treatment with other EGFR tyrosine kinase inhibitors, such as gefitinib, erlotinib, and afatinib.
In the US, EGFR exon 19 deletions, exon 21 L858R mutations, or the T790M status of the patient before treatment with osimertinib must be detected by a companion diagnostic test. The Food and Drug Administration (FDA) has approved multiple tests, including FoundationOne CDx for this purpose. In Europe and elsewhere, activating EGFR mutations or T790M mutations may be determined by a validated test.
In February 2024, the FDA approved osimertinib, in combination with platinum-based chemotherapy, for people with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
In people treated with osimertinib, resistance usually develops within approximately ten months. Resistance mediated by an exon 20 C797S mutation accounts for the majority of resistance cases, which has resulted in multiple attempts with non-ATP competitive or allosteric inhibitors to try and offset this acquired resistance by targeting other regions of the RTK kinase domain.
In September 2024, the FDA approved osimertinib for adults with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
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Osimertinib
Osimertinib, sold under the brand name Tagrisso, is a medication used to treat non-small-cell lung carcinomas with specific mutations. It is a third-generation epidermal growth factor receptor tyrosine kinase inhibitor.
The most common side effects include diarrhea, rash, musculoskeletal pain, dry skin, skin inflammation around nails, sore mouth, fatigue, and cough.
Osimertinib was approved for medical use in the United States in November 2015, and in the European Union in February 2016.
Osimertinib is used to treat locally advanced or metastatic non-small-cell lung cancer (NSCLC), if the cancer cells are positive for the T790M mutation in the gene coding for EGFR or for activating EGFR mutations. The T790M mutation may be de novo or acquired following first-line treatment with other EGFR tyrosine kinase inhibitors, such as gefitinib, erlotinib, and afatinib.
In the US, EGFR exon 19 deletions, exon 21 L858R mutations, or the T790M status of the patient before treatment with osimertinib must be detected by a companion diagnostic test. The Food and Drug Administration (FDA) has approved multiple tests, including FoundationOne CDx for this purpose. In Europe and elsewhere, activating EGFR mutations or T790M mutations may be determined by a validated test.
In February 2024, the FDA approved osimertinib, in combination with platinum-based chemotherapy, for people with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
In people treated with osimertinib, resistance usually develops within approximately ten months. Resistance mediated by an exon 20 C797S mutation accounts for the majority of resistance cases, which has resulted in multiple attempts with non-ATP competitive or allosteric inhibitors to try and offset this acquired resistance by targeting other regions of the RTK kinase domain.
In September 2024, the FDA approved osimertinib for adults with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
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