Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EGFR Exon 19 (Deletion) status confers therapeutic sensitivity to Carboplatin, Osimertinib, Pemetrexed in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug Administration granted approval to osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. This indication is based on FLAURA2 (NCT04035486), a randomized, multicenter, and open-label trial where patients were randomized to receive either osimertinib or osimertinib in combination with pemetrexed and investigator's choice of either cisplatin or carboplatin.
This statement is based on a regulatory approval from the Food and Drug Administration:
TAGRISSO is a kinase inhibitor indicated in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.