FDAsafety guidance83% confidence
Ongoing | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to AstraZeneca.
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 · Combination Therapy
- Sub-indication
- General
Related signal: Phase Ib/II Trial of Olaparib with AZD2014 or AZD5363 in Recurrent Endometrial and Ovarian Cancer