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FDA

Regulatory intelligence
FDAapproval54% confidence

Withdrawn | Cancer Accelerated Approvals

Source: FDA

Why This Matters

Why this matters: sets a approval precedent in the same sub-indication (lung cancer) as AstraZeneca.

Regulatory Analysis

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved.

Supporting Context

Therapeutic area
Oncology · EGFR Inhibitor
Sub-indication
Lung Cancer

Related signal: AstraZeneca licenses novel EGFR inhibitor Zegfrovy for lung cancer

Source

View source document

Related Signal

Open signal — AstraZeneca licenses novel EGFR inhibitor Zegfrovy for lung cancer
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