FDA records show two osimertinib approvals for non-small cell lung cancer
One record covers osimertinib with chemotherapy for EGFR-mutated disease, while a separate record confirms approval for stage III disease following chemoradiation without specifying mutation status.
FDA records document two separate approvals involving osimertinib in non-small cell lung cancer.
One record states that FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer1. The record does not provide additional detail on dosing, trial data, or the specific date of this approval.
A second, dated record confirms that on September 25, 2024, the FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer2. This approval is specified for patients whose disease follows chemoradiation therapy. The record does not state whether this stage III indication is limited to patients with EGFR-mutated tumors; the EGFR-mutated qualifier appears only in the separate record describing the chemotherapy combination approval.
Taken together, the two FDA records indicate osimertinib has been approved in at least two distinct non-small cell lung cancer settings: one combined with chemotherapy and explicitly tied to EGFR mutation status, and one tied to stage III disease following chemoradiation therapy, dated September 25, 2024, without an explicit EGFR mutation qualifier in the available text. No further details on trial endpoints, dosing regimens, or additional approval conditions are included in either record.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.