AstraZeneca Says US FDA Okays Tagrisso For Lung Cancer Type

Cornelia Mascio
Aprile 20, 2018

AstraZeneca announced that the Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) as first-line treatment for patients with epidermal growth factor receptor (EGFR)-mutated (exon 19 deletions or exon 21 L858R mutations) metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

The FDA based this approval on the results from the phase 3 FLAURA trial of 556 previously untreated patients with locally advanced or metastatic EGFR-mutated NSCLC. "The approval of osimertinib in the first-line setting represents a major advance in the treatment of patients with EGFR mutations and a significant change in the treatment paradigm", Suresh S. Ramalingam, MD, principal investigator of the FLAURA trial, said in the press release. Patients received a daily oral therapy of osimertinib (80 mg), gefitinib (250 mg), or erlotinib (150 mg).

The safety profile appeared consistent with previous clinical trials.

The PFS benefit with osimertinib extended across all prespecified subgroups. For patients with CNS metastases (n = 116), the median PFS with osimertinib was 15.2 months (95% CI, 12.1-24.4) compared to 9.6 months (95% CI, 7.0-12.4) with standard therapy (HR, 0.47; 95% CI, 0.30-0.74; P =.0009). In those without CNS involvement (440 patients), the median PFS was 19.1 months and 10.9 months, for Tagrisso and the control arm, respectively.

The objective response rate with Tagrisso was 77 percent compared with 69 percent for Tarceva or Iressa. At the time of the analysis, there had been 58 deaths in the osimertinib arm and 83 in the control group. The most common adverse reactions associated with osimertinib were diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue, and decreased appetite.

Overall, 33.7% of patients experienced a grade ≥3 AE in the osimertinib group compared with 44.8% for erlotinib and gefitinib. Patients in the Tagrisso group were less likely to discontinue treatment because of side effects (13.3 percent vs. 18.1 percent).

AstraZeneca's Tagrisso looks set to gain further traction after the FDA approved it in first-line treatment for lung cancer patients with a certain mutation.

Osimertinib is a third-generation, irreversible EGFR TKI created to inhibit both EGFR-sensitizing and EGFR T790M-resistance mutations, with clinical activity against CNS metastases. In September 2017, the NCCN Clinical Practice Guidelines in Oncology recommended first-line osimertinib for patients with locally-advanced or metastatic EGFR mutation-positive NSCLC.

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