FDA Expands Approval of Tagrisso in NSCLC

Based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival by more than three years in unresectable, stage III, EGFR positive NSCLC

Charles H. Weaver, MD
2–3 minutes
Home » Lung Cancer » FDA Expands Approval of Tagrisso in NSCLC

The FDA has expanded approval of osmertinib (Tagrisso) to include treatment of adults with stage III non-small cell lung cancer (NSCLC) that cannot be surgically removed. This expanded approval is specifically for patients whose cancer:

  • Has not gotten worse during or after chemotherapy and radiation treatment
  • Has certain genetic changes (EGFR exon 19 deletions or exon 21 L858R mutations)

Osmertinib is also approved for the following:

  • adjuvant therapy after tumor resection in adult patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.
  • the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.
  • in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.
  • the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after EGFR TKI therapy.

Key Points from the Study

Expanded approval of osimertinib was based on efficacy and safety data from the LAURA study.

  • Patients who took osimertinib went about 39 months before their cancer worsened, compared to only 5.6 months for those who didn’t take it
  • After one year, 74% of patients on osimertinib had no cancer progression, compared to 22% in the placebo group
  • After two years, 65% of osimertinib patients still had no progression, versus 13% in the placebo group

Side Effects

Common side effects included low blood cell counts, lung inflammation, skin rash, diarrhea, nail problems, muscle/bone pain, cough, and COVID-19 infection.

What This Means for Patients

This approval offers a new targeted treatment option for certain stage III NSCLC patients after initial chemoradiation therapy. It significantly extends the time before cancer progresses, potentially improving outcomes for eligible patients.

More Reading

Newly Diagnosed With Lung Cancer? What Every Patient Should Know

The Importance of Molecular Testing

Precision Medicines & Immunotherapy

Must Read Tips for Beating Lung Cancer

Connect With Others for Support and Information

Cancer Connect was the first social network created for people with cancer. Founded by oncologists to support cancer patients and their caregivers, over 40 million individuals have accessed Cancer Connect programs since 1997. Cancer Connect is used by leading cancer centers including Dana Farber to support their patients. Share your experience, ask a question, or start a conversation by joining Cancer Connect.

References

  1. FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy. FDA. September 25, 2024. Accessed September 25, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-locally-advanced-unresectable-stage-iii-non-small-cell-lung-cancer
  2. Ramalingam SS, Kato T, Dong X, et al. Osimertinib (osi) after definitive chemoradiotherapy (CRT) in patients (pts) with unresectable stage (stg) III epidermal growth factor receptor-mutated (EGFRm) NSCLC: primary results of the phase 3 LAURA study. J Clin Oncol. 2024;42(suppl 17):LBA4. doi:10.1200/JCO.2024.42.17_suppl.LBA4
,

You May Be Interested In