AZ gets sought-after lung cancer approval for Tagrisso

AstraZeneca's EGFR inhibitor Tagrisso has been approved by the FDA for a new lung cancer indication that could make it a go-to therapy for a patient population that until now had no targeted treatments.

The US regulator has cleared Tagrisso (osimertinib) for patients with stage 3 non-small cell lung cancer (NSCLC) expressing EGFR exon 19 or exon 21 (L858R) mutations that cannot be treated with surgery and has been previously treated with chemoradiotherapy.

The approval comes after a priority review by the FDA and is based on the LAURA trial, which was a highlight of this year's ASCO congress and led to speculation that Tagrisso could become the standard of care for this group of patients, who tend to have a very high rate of disease recurrence.

At the show, ASCO discussant Lecia Sequist of Massachusetts General Hospital and Harvard Medical School hailed the "phenomenal, clinically meaningful primary result, which is immediately practice changing in my opinion."

Compared to placebo, Tagrisso reduced the risk of disease progression or death by 84% in LAURA, with a median progression-free survival (PFS) of 39.1 months, while the control group came in at less than six months. There was also a trend towards improved overall survival, although that data is not yet mature.

AZ has previously said that the LAURA results, combined with the ADAURA study of Tagrisso as adjuvant treatment of EGFR-positive NSCLC, show that EGFR inhibitors can have a dramatic impact in early-stage lung cancer and should be used as early as possible in the treatment pathway.

Tagrisso is already AZ's second-best-selling drug, with sales of $5.8 billion last year, but is starting to face the threat of competition from other drugs, including Johnson & Johnson's fast-growing EGFRxMET bispecific antibody Rybrevant (amivantamab), which has been tipped as a future $5 billion-a-year product.

In a statement, AZ's head of oncology, Dave Fredrickson, said the new approval "addresses a critical need for patients with these mutations who have never had the option of targeted therapy before."

He went on to say that 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."

Tagrisso is already approved for patients with EGFR mutations in the frontline metastatic setting as a monotherapy and in combination with chemotherapy, and as an adjuvant treatment for early-stage disease.