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FDA

Regulatory intelligence
FDAsafety guidance72% confidence

Ongoing | Cancer Accelerated Approvals

Source: FDA

Why This Matters

Why this matters: sets a safety guidance precedent in the same sub-indication (lung cancer) as Bristol Myers Squibb.

Regulatory Analysis

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.

Supporting Context

Therapeutic area
Oncology · Non-Small Cell Lung Cancer
Sub-indication
Lung Cancer

Related signal: Bristol-Myers Squibb Evaluates Pumitamig vs Pembrolizumab in NSCLC Trial

Source

View source document

Related Signal

Open signal — Bristol-Myers Squibb Evaluates Pumitamig vs Pembrolizumab in NSCLC Trial
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