AZ gets EU okay for Tagrisso in early-stage lung cancer

 AstraZeneca's EGFR inhibitor Tagrisso has become the first drug in the class to be approved in the EU as a treatment for a specific form of locally advanced, unresectable non-small cell lung cancer (NSCLC).

The European Commission has approved Tagrisso (osimertinib) for this indication in patients with stage 3 tumours that have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (CRT).

The highly anticipated approval comes on the back of the LAURA trial, which was a highlight of this year's ASCO congress and has been tipped to become an important new indication for Tagrisso, currently AZ's second best-selling drug, with sales of almost $4.9 billion in the first nine months of this year.

The results showed that Tagrisso reduced the risk of disease progression or death by 84% compared to placebo, with progression-free survival (PFS) of 39.1 months and 5.6 months, respectively.

At ASCO, the stellar PFS data sparked speculation that Tagrisso will become the standard of care in this type of early lung cancer, which until now had no targeted therapies approved in the EU. The drug was approved in the US for the same indication in September.

AZ has previously said that the LAURA results, combined with the ADAURA study of Tagrisso as adjuvant treatment of EGFR-positive NSCLC, which was a highlight of the 2023 ASCO conference, 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.

That's important for AZ, as Tagrisso is starting to face the threat of competition from other EGFR drugs, including Johnson & Johnson's fast-growing EGFRxMET bispecific antibody Rybrevant (amivantamab), which has previously been tipped as a future $5 billion-a-year product, although a recent FDA complete response letter has tarnished its lustre.

The head of AZ's oncology business unit, Dave Fredrickson, said that the LAURA results and Tagrisso approval "reinforces the importance of timely EGFR testing and solidifies Tagrisso as the backbone therapy" for EGFR-mutated NSCLC, spanning early to late-metastatic settings.

"Tagrisso is now the first and only EGFR inhibitor and targeted treatment approved in the EU for locally advanced, unresectable lung cancer, providing a new standard of care to patients who have historically experienced early progression after chemoradiation therapy," he added.

Tagrisso is already approved for patients with EGFR mutations in the frontline metastatic setting, both as a monotherapy and in combination with chemotherapy and as an adjuvant treatment for early-stage disease, but AZ has said that new studies like the LAURA trial will be "excellent growth drivers."

Earlier this year, the drug also showed its potential as an all-oral therapy alongside AZ's cMET inhibitor Orpathys (savolitinib) in the SAVANNAH trial involving patients with EGFR-mutated NSCLC that has progressed after earlier Tagrisso therapy. The confirmatory SAFFRON study in that indication is due to read out next year.

https://pharmaphorum.com/news/az-gets-eu-okay-tagrisso-early-stage-lung-cancer