Risk Minimization of Antibody-Drug Conjugates in Oncology: A Review.

Antibody-drug conjugates (ADCs) are new treatment options for certain cancers, especially those in advanced states with limited treatment options. Their unique design provides targeted therapy with toxins that otherwise would not be available, but they manifest toxicities that require risk minimization interventions to optimize their tolerability. We summarize selected toxicities for ADCs that have been approved through the end of 2020 and three investigational ADCs, which include both payload and linker, as described in the US Prescribing Information, the European Summary of Product Characteristics, and study protocols.

Pericardial effusion coincident with sirolimus therapy: a review of Wyeth's safety database.

Sirolimus is an immunosuppressive agent approved for prophylaxis of acute rejection in renal transplant patients aged 13 years or older. A retrospective review of pericardial effusion coincident with sirolimus therapy was conducted from key clinical trials and spontaneous reporting sources. A significantly higher rate of pericardial effusion occurred with sirolimus versus azathioprine treatment in a cardiac transplantation trial (28.