Osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) has received another new indication, this time having been approved for adult patients with stage 3 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.1,2
Researchers evaluated the treatment’s efficacy in the LAURA (NCT03521154) trial, a double-blind, placebo-controlled trial in 216 adult patients who were randomly assigned (2:1) to receive either osimertinib 80 mg orally once daily or placebo until disease progression or unacceptable toxicity.
Osimertinib demonstrated a statistically significant improvement in progression-free survival (PFS) compared to placebo, with a hazard ratio of 0.16 (95% CI, .10-.24; P<.001). The median PFS was 39.1 months (95% CI, 31.5, not estimable [NE]) in the osimertinib arm and 5.6 months (95% CI, 3.7-7.4) in the placebo arm.
While OS results were immature at the current analysis, with 36% of prespecified deaths for the final analysis reported, no trend toward a detriment was observed.
The most common adverse reactions were lymphopenia, leukopenia, interstitial lung disease/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough, and COVID-19 infection.
This review was conducted under Project Orbis, an FDA framework that provides for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration, Health Canada, and Switzerland’s Swissmedic. The application reviews are ongoing at the other regulatory agencies.
References
- Tagrisso (osimertinib) with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer. Press release. AztraZeneca. Published February 16, 2024. Accessed October 10, 2024. www.astrazeneca-us.com/media/press-releases/2024/tagrisso-osimertinib-with-the-addition-of-chemotherapy-approved-in-the-us-for-patients-with-egfr-mutated-advanced-lung-cancer.html
- FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy. FDA. September 25, 2024. Accessed October 10, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-locally-advanced-unresectable-stage-iii-non-small-cell-lung-cancer#:~:text=On%20September%2025%2C%202024%2C%20the,concurrent%20or%20sequential%20platinum%2Dbased