Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EGFR p.L858R status confers therapeutic sensitivity to Carboplatin, Osimertinib in patients with Non-Small Cell Lung Cancer.
The European Medicines Agency (EMA) has authorized osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions over exon 21 (L858R) substitution variants. This indication is based on the randomized, open-label, active-controlled trial FLAURA2 where the treatment arm with chemotherapy was investigator's choice of cisplatin (75 mg/m^2) or carboplatin (AUC).
This statement is based on a regulatory approval from the European Medicines Agency:
TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.