AstraZeneca’s blockbuster lung cancer treatment Tagrisso scored a new FDA approval on Thursday in certain EGFR-mutated early-stage patients whose non-small cell lung cancer has not spread, but can’t be removed through surgery.
The company’s immunotherapy Imfinzi has been a standard treatment in this population, according to Mohit Manrao, the senior VP of AstraZeneca’s US oncology business unit. But he said that EGFR-mutated patients are likely to do better on a targeted therapy like Tagrisso. Otherwise known as osimertinib, Tagrisso is now approved for use after chemoradiotherapy in unresectable, stage 3 patients with exon 19 deletions or exon 21 (L858R) mutations, two of the most common non-small cell lung cancer mutations.
Of 200,000 patients in the US diagnosed with lung cancer each year, 80% to 85% have non-small cell lung cancer, and 15% of those patients have EGFR mutations, Manrao said.
The approval came earlier than expected. AstraZeneca previously said the FDA would likely announce a decision in the fourth quarter of 2024. Tagrisso is already approved for use as a monotherapy in metastatic non-small cell lung cancer patients, as an adjuvant treatment in patients with early-stage cancer after surgery, and in combination with chemotherapy in more advanced patients.
Mohit Manrao“Tagrisso is the backbone now available to every patient at every stage, which has been our mission with this drug, given the impact it has on those patients,” Manrao told Endpoints News.
Tagrisso is also the backbone of AstraZeneca’s oncology portfolio, generating the unit’s highest 2023 sales at nearly $5.8 billion. Imfinzi was close behind, at $4.2 billion.
The approval was based on Phase 3 data which suggested Tagrisso reduced patients’ risk of disease progression or death by 84% compared to placebo (p<0.001). Median progression-free survival was 39.1 months in the Tagrisso arm versus 5.6 months in the placebo arm. Overall survival data were not mature at the time of the readout, Manrao said, adding that AstraZeneca will follow up.
“Hopefully at some point when the data is mature enough — it’s an event-driven rate — we will be able to show more information,” he said.