FDA Approves Tagrisso for Unresectable Stage III Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer

Image Credit: Adobe Stock Images/Sebastian Kaulitzki

The FDA has approved AstraZeneca’s Tagrisso for adults with unresectable stage III epidermal growth factor receptor-mutated (EGFR) non-small cell lung cancer (NSCLC) whose disease has not progressed after platinum-based chemoradiation therapy. The treatment, which targets patients with exon 19 deletions or exon 21 (L858R) mutations, was approved under Priority Review based on results from the Phase III LAURA trial.¹

“This approval represents a major breakthrough for patients with Stage III, EGFR-mutated lung cancer who will now have the opportunity to benefit from osimertinib. Patients treated with osimertinib lived without disease progression by more than three years in the LAURA trial, and this impressive benefit underscores the importance of diagnosing and testing lung cancer patients as early as possible,” said Suresh Ramalingam, MD, executive director, Winship Cancer Institute, Emory University, Atlanta, in a press release.

The randomized, double-blind, placebo-controlled, multi-center, global LAURA trial was conducted across 145 sites in 15 countries, including the United States, Europe, South America, and Asia. As part of the trial, 216 patients were treated with Tagrisso 80 mg once-daily oral tablets until disease progression, unacceptable toxicity, or other discontinuation criteria were met. Additionally, patients in the placebo arm were offered Tagrisso upon progression. The primary endpoint of the study was progression-free survival (PFS). As the trial is ongoing, researchers will continue to assess the secondary endpoint of overall survival.

Results found that Tagrisso reduced the risk of disease progression or death by 84% compared to placebo, with a median PFS of 39.1 months in the Tagrisso group compared with 5.6 months in the placebo group.

The safety profile of Tagrisso was consistent with its established profile and no new safety concerns were identified.¹ AstraZeneca warns that Tagrisso can cause a number of serious adverse events (AEs), such as lung problems, heart failure, issues with eyes and skin, inflammation of blood vessels in the skin, and issues with blood and bone marrow. Common AEs include tiredness; mouth sores; dry skin; rash; diarrhea; low white blood cell counts; low platelet counts; anemia; muscle, bone, or joint pain; changes in nails such as tenderness; and an increase of creatinine in the blood.²

AstraZeneca reports that each year, an estimated 2.4 million people are diagnosed with lung cancer globally. Anywhere from 10% to 15% of NSCLC patients reside in the United States or Europe. Additionally, 30%-40% of patients in Asia have EGFRm NSCLC.¹ The American Cancer Society states that around 80% to 85% of all lung cancers are NSCLC, with the majority being diagnosed in the advanced stages of the disease.^1,3 In the United States, it is currently the leading cause of cancer deaths, accounting for a fifth of cancer-related mortalities annually. The average diagnosis age for lung cancer is 70 years.³

“The approval of Tagrisso for patients with Stage III, unresectable EGFR-mutated non-small cell lung cancer addresses a critical need for patients with these mutations who have never had the option of targeted therapy before. The results of the LAURA trial show the powerful impact Tagrisso can make as backbone therapy in this disease, and with this approval, patients across all stages of EGFR-mutated non-small cell lung cancer can now benefit,” said Dave Fredrickson, EVP, oncology business unit, AstraZeneca, in the press release.

At this time, Tagrisso is under review with regulatory authorities in numerous countries for treating unresectable stage III EGFR NSCLC.¹

References

1. Tagrisso approved in the US for patients with unresectable, Stage III EGFR-mutated lung cancer. AstraZeneca. September 26, 2024. Accessed September 26, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-us-approval-in-unresectable-lung-cancer.html

2. Important Safety Information. Tagrisso. Accessed September 26, 2024. https://www.tagrisso.com/?source=tag_d_c_3&umedium=cpc&uadpub=google&ucampaign=2024tagrissobranded_information_dtc&ucreative=branded_sideeffects_ex&uplace=tagrissoadverseeffects&outcome=dtc&cmpid=1&gclid=Cj0KCQjwjNS3BhChARIsAOxBM6pcHuE6cDQpLKwCdFBtLUo-txN8efnOhjqWqpxPUW8u-EonqZSVXHAaAvuyEALw_wcB&gclsrc=aw.ds

3. Key Statistics for Lung Cancer. American Cancer Society. Accessed September 26, 2024. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html#:~:text=Overall%2C%20the%20chance%20that%20a,t%2C%20the%20risk%20is%20lower.