Astrazeneca Tagrisso gets key lung cancer FDA nod

 In June, at the American Society of Clinical Oncology (ASCO) conference in Chicago, when AstraZeneca discussed results from a phase 3 trial of its non-small cell lung cancer (NSCLC) blockbuster Tagrisso, the presentation received a standing ovation. 

Three months later, the FDA has added its acclamation, signing off on Tagrisso to become the first targeted therapy for unresectable, stage 3 epidermal growth factor receptor-mutated (EGFRm) NSCLC. It has been approved for patients with exon 19 deletions or exon 21 (L858R) mutations who cannot be treated with surgery and have been previously treated with chemotherapy.

The endorsement further bolsters Tagrisso’s status as the top EGFR inhibitor in metastatic NSCLC and as a postsurgical adjuvant therapy for resectable tumors.

Why all the accolades for a treatment that is already dominant in NSCLC? The excitement comes from the results of the LAURA study, which showed that Tagrisso reduced the risk of disease progression or death by a whopping 84% compared to placebo.

Patients on Tagrisso lived a median 39.1 months without disease progression versus 5.6 months for those on placebo. Two years after treatment, 6% of patients on Tagrisso developed brain metastases compared with 28% in the control group. The tumor-progression benefit was seen across key subgroups, including in stage 3a, 3b or 3c tumors, according to full results published in The New England Journal of Medicine.

The approval is a “major breakthrough” for patients in the indication, the trial’s principal investigator, Suresh Ramalingham, M.D., said in a release.

“This impressive benefit underscores the importance of diagnosing and testing lung cancer patients as early as possible” said Ramalingham, who is the executive director of the Winship Cancer Institute of Emory University in Atlanta.

Data on patients’ life expectancy in the LAURA trial remained immature but have already showed a favorable trend toward the AZ medicine, suggesting a preliminary 19% reduction in the risk of death for Tagrisso versus placebo. That’s despite 81% of patients in the placebo arm having received Tagrisso following disease progression. Mature data will be available around the end of 2025, Ramalingham said at ASCO.

Tagrisso gained its first FDA approval in 2015 and has since tacked on nods to treat first-line EGFRm NSCLC in 2018, as an adjuvant treatment for patients with early-stage NSCLC in 2020 and for use alongside chemotherapy early this year. Tagrisso was AZ’s second best-selling drug in 2023, generating revenue of $5.8 billion.

Tagrisso is not without challengers however in NSCLC. Johnson & Johnson’s bispecific antibody Rybrevant, which was originally approved in 2021, has racked up three FDA nods in the last seven months and has been pegged with a peak sales potential of $5 billion.

Each year, an estimated 2.4 million people are diagnosed with lung cancer worldwide. Lung cancer accounts for about one-fifth of all cancer deaths and is split into NSCLC and small cell lung cancer. Roughly 30,000 are diagnosed with EGFR-mutated NSCLC each year in the U.S. 

https://www.fiercepharma.com/pharma/talk-town-chicago-astrazenecas-tagrisso-follows-key-nsclc-nod