Complete response (CR)
Oncology· appears in 400+ cited findings in this library
What it is and how the reviews use it
Complete response (CR) is an endpoint used in regulatory review documents to measure the effectiveness of a treatment, often in oncology trials. It signifies the disappearance of all target lesions and any pathological evidence of disease. While the definitional facts do not specify a range or severity bands, its functional use in the provided documents indicates it serves as a critical measure of treatment success, frequently appearing as a rate (e.g., "Complete response rate"). It is utilized across various trial phases and can be a primary or secondary endpoint.
The reviews in this library use Complete response (CR) to report treatment outcomes for various drugs. For instance, the Incyte Corporation — Minjuvi EMA EPAR variation assessment report (EME) notes a "Complete response rate" of 77%. The ASTRAZENECA — Faslodex FDA Review (NDA/BLA 021344, 2019) reports a "Complete Response (fulvestrant 250 mg)" of 0.4%. Additionally, the BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2020) shows a "complete response rate by IRRC in all MSIH/dMMR mCRC patients" of 2.7%. Variations like "Stringent Complete Response (sCR)" and "Pathological Complete Response (pCR)" are also observed, indicating specific criteria for complete response.
Real examples — cited to the source page
| Minjuvi | Complete response rate | 77 | Incyte Corporation — Minjuvi EMA EPAR variation assessment report (EME, p.12 |
| Faslodex | Complete Response (fulvestrant 250 mg) | 0.4 | ASTRAZENECA — Faslodex FDA Review (NDA/BLA 021344, 2019), p.83 |
| Opdivo | complete response rate by IRRC in all MSIH/dMMR mCRC patients | 2.7 | BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2020), p.139 |
| Keytruda | Complete response rate | 0.3 | MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2023), p.64 |
| Tagrisso | Complete Response (CR) excluding patients with protocol violation | 0.27 | AstraZeneca PLC — Tagrisso FDA Review (NDA208065, ORIG 1, 2015), p.52 |
| Carvykti | Stringent Complete Response (sCR) rate (All-treated analysis set) | 80.4% | Johnson & Johnson — Carvykti EMA EPAR public assessment report (EMEA/H, p.75 |
| Tecartus | Complete Response (CR) rate for KTE-X19 (Inferential Analysis Set) | 67 | Gilead Sciences, Inc. — Tecartus EMA EPAR public assessment report (EM, p.63 |
| Ojemda | Complete Response (CR) | 0 | Ipsen S.A. — Ojemda EMA EPAR public assessment report (EMEA/H/C/006140, p.102 |
Different drugs were studied in different trials — these values are not head-to-head comparisons.
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Figures are as stated in the cited source documents. Educational reference only — not medical or investment advice.