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  6. FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy
  1. Resources for Information | Approved Drugs

FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy

On September 25, 2024, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients 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.

Full prescribing information for Tagrisso will be posted on Drugs@FDA.

Efficacy and Safety

Efficacy was evaluated in LAURA (NCT03521154), a double blind, randomized, placebo-controlled trial in 216 adult patients with locally advanced, unresectable stage III NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations who had not progressed during or following definitive platinum-based chemoradiation within 42 days prior to study randomization. Patients were randomized (2:1) to receive either osimertinib 80 mg orally once daily or placebo until disease progression or unacceptable toxicity.

The major efficacy outcome measure was progression free survival (PFS) as assessed by blinded independent central review. Additional efficacy outcome measures included overall survival (OS). Osimertinib demonstrated a statistically significant improvement in PFS compared to placebo with a hazard ratio of 0.16 (95% CI: 0.10, 0.24; p-value <0.001). 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 pre-specified deaths for the final analysis reported, no trend towards a detriment was observed.

The most common adverse reactions, including laboratory abnormalities (≥20%), were lymphopenia, leukopenia, interstitial lung disease/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough, and COVID-19 infection.

The recommended osimertinib dose is 80 mg once daily, with or without food, until disease progression or unacceptable toxicity.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), Health Canada, and Switzerland’s Swissmedic. The application reviews are ongoing at the other regulatory agencies.

Expedited Programs

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted priority review and breakthrough designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Follow the Oncology Center of Excellence on X: @FDAOncology.

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