AstraZeneca Submitted Lung Cancer Drug Application to FDA
The company seeks approval for a targeted combination therapy for patients with specific genetic mutations.
Updated on Sept. 29, 2026 in Cancer
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AstraZeneca has submitted a new drug application to the FDA for the combination of savolitinib and osimertinib. This treatment is intended for patients with MET-driven, EGFR-mutated non-small cell lung cancer whose disease progressed on prior therapy.
Why it matters
The therapy targets a common resistance mechanism where approximately 34% of tumors develop high levels of MET overexpression after treatment with third-generation EGFR inhibitors. The application relies on clinical data demonstrating improved progression-free and overall survival rates.
The SACHI trial enrolled 211 patients to test the efficacy of 300 mg of savolitinib twice daily and 80 mg of osimertinib once daily. Grade 3 or higher treatment-emergent adverse effects occurred in 57% of patients in both treatment arms.
The players
AstraZeneca
This is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines.
FDA
The United States Food and Drug Administration is the federal agency responsible for protecting public health by ensuring the safety and efficacy of human drugs.
The details
The treatment combines savolitinib, a selective MET TKI, with osimertinib, an irreversible third-generation EGFR TKI. The SAFFRON trial, which informs the filing, enrolled 338 patients across 230 centers in 29 countries to assess MET status through protein overexpression and gene amplification.
Timeline
August 2026: Companies reported high-level SAFFRON trial results.
September 29, 2026: Article publication date.
The Big Picture
The filing follows a documented trend of targeted therapies addressing acquired resistance mechanisms in lung cancer patients. It follows the precedent established by the SAFFRON trial, which provides the clinical roadmap for using MET-directed treatments after initial EGFR-targeted therapy fails.
The application offers a potential new treatment path for patients whose lung cancer has developed resistance to standard EGFR therapies. Patients and their oncologists may eventually have access to a combination regimen that demonstrated a higher progression-free survival rate than chemotherapy.
The takeaway
Patients facing disease progression after initial therapy may soon have a more effective, targeted option that bypasses MET-driven resistance. Clinicians should monitor the upcoming 2026 ESMO Congress for the full SAFFRON trial dataset to better understand the safety profile of this combination.
What happens next
Full results from the global phase 3 SAFFRON trial are scheduled for presentation at the 2026 ESMO Congress.
Further reading
For more information on the latest developments in oncology, visit our Cancer section.
Source note: This article includes information reported by OncLive.
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