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Pathological complete response (pCR)

Oncologyยท appears in 12+ cited findings in this library

What it is and how the reviews use it

Pathological complete response (pCR) is an endpoint used in clinical trials, particularly in oncology, to assess the effectiveness of a treatment. It serves as a measure of the complete disappearance of invasive cancer cells in surgical specimens following neoadjuvant therapy. While the provided documents do not explicitly define its range or severity bands, its functional use indicates it is a critical metric for evaluating treatment efficacy.

Regulatory reviews in this library utilize pCR to quantify treatment outcomes across various drugs. For instance, the Tevimbra EMA EPAR variation assessment report shows a Pathological Complete Response (pCR) rate of 5.7%. In the Phesgo EMA EPAR public assessment report, the Total pathological complete response (tpCR) rate in the PH FDC SC arm (ITT population) was 59.7%. Additionally, the Padcev EMA EPAR variation assessment report highlights a pCR difference in response rates of 48.3%.

Real examples โ€” cited to the source page

TevimbraPathological Complete Response (pCR) rate5.7 %BeOne Medicines Ltd. โ€” Tevimbra EMA EPAR variation assessment report, p.118
PhesgoTotal pathological complete response (tpCR) rate in PH FDC SC arm (ITT population)59.7 %Roche Holding AG โ€” Phesgo EMA EPAR public assessment report, p.75
PadcevpCR difference in response rates48.3 %Astellas Pharma Inc. โ€” Padcev EMA EPAR variation assessment report, p.76

Different drugs were studied in different trials โ€” these values are not head-to-head comparisons.

Explore the full evidence

Every Pathological finding in the library โ€” searchable and answerable in plain language โ€” is in the Oncology research library โ†’

Figures are as stated in the cited source documents. Educational reference only โ€” not medical or investment advice.

Pathological complete response (pCR) โ€” Explained with Cited FDA & EMA Examples | BioPharmaPT Oncology