Tumours respond differently to immunotherapies compared with chemotherapeutic drugs,
raising questions about the assessment of changes in tumour burden—a mainstay of …

Importance The US Food and Drug Administration's (FDA's) accelerated approval pathway
allows investigational cancer drugs to be approved by demonstrating a beneficial effect on a …

Objective To determine the availability of data on overall survival and quality of life benefits
of cancer drugs approved in Europe. Design Retrospective cohort study. Setting Publicly …

Importance A common justification for high cancer drug prices is the sizable research and
development (R&D) outlay necessary to bring a drug to the US market. A recent estimate of …

Angiogenesis is a double-edged sword; it is a mechanism that defines the boundary
between health and disease. In spite of its central role in physiological homeostasis, it …

METHODS We used a decision analytic Markov model informed by recent multicenter,
single-arm trials to evaluate axi-cel and tisagenlecleucel in multiply relapsed/refractory …

Background Surrogate outcomes are not intrinsically beneficial to patients, but are designed
to be easier and faster to measure than clinically meaningful outcomes. The use of …

Background Surrogates are frequently used in cancer medicine as the end-point of clinical
trials and as the basis of United States Food and Drug Administration approvals, but they do …

Importance Drugs treating serious or life-threatening conditions can receive US Food and
Drug Administration (FDA) accelerated approval based on showing an effect in surrogate …

Important breakthroughs in medical treatments have improved outcomes for patients
suffering from several types of cancer. However, many oncological treatments approved by …