Minimal residual disease (MRD)
Oncology· appears in 272+ cited findings in this library
What it is and how the reviews use it
Minimal residual disease (MRD) negativity is an endpoint used in regulatory review documents to assess the presence of very small numbers of cancer cells that remain in the body after treatment. It is a measure of treatment effectiveness, indicating a deeper response than traditional remission criteria. The endpoint is often reported with a specific sensitivity level, such as 10^-4 or 10^-5, which refers to the detection limit of the method used to identify residual disease.
In the regulatory reviews, MRD negativity is frequently used to evaluate the efficacy of various cancer therapies. For instance, the Johnson & Johnson Carvykti EMA EPAR report notes a MRD negativity in bone marrow at 10^-5 sensitivity of 91.8%. The AbbVie Inc. Venclexta FDA Review reported a MRD negativity rate in bone marrow (Obinutuzumab + Chlorambucil) of 37. Similarly, the Sanofi Sarclisa EMA EPAR report indicates 10 patients achieved MRD negative at 10^-4.
Real examples — cited to the source page
| Carvykti | MRD negativity in bone marrow at 10-5 sensitivity | 91.8% | Johnson & Johnson — Carvykti EMA EPAR, p.103 |
| Venclexta | MRD negativity rate in bone marrow (Obinutuzumab + Chlorambucil) | 37 | AbbVie Inc. — Venclexta FDA Review, p.45 |
| Sarclisa | MRD negative at 10-4 | 10 | Sanofi — Sarclisa EMA EPAR, p.81 |
| Ninlaro | overall remission rate (CR + CR MRD- + CRi) | 66% | Takeda Pharmaceutical Company Limited — Ninlaro EMA EPAR, p.19 |
| Lynozyfic | MRD negativity rate | 37.3 | Regeneron Pharmaceuticals, Inc. — Lynozyfic EMA EPAR, p.79 |
| Talvey | MRD Negativity Rate (10-5) | 30.8 | Unknown MAH — Talvey EMA EPAR, p.80 |
| Abecma | MRD-negative status and >= CR | 25.8 | Bristol-Myers Squibb Company — Abecma EMA EPAR, p.83 |
| Gazyvaro | MRD negative (%) | 2.5 | Roche Holding AG — Gazyvaro EMA EPAR, p.80 |
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.