Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Expanded Access benefits heavily pretreated patients, especially children

Publish date:: March 7, 2019

Key clinical point: Single-patient use (SPU) of investigational therapies via the Food and Drug Administration’s Expanded Access program is an option worth considering for heavily pretreated cancer patients.

Major finding: The overall response rate to SPUs was 20.1%.

Study details: A retrospective study involving 179 patients from Memorial Sloan Kettering Cancer Center.

Disclosures: The study was funded by National Institutes of Health, the St. Baldrick’s Foundation, and the Nonna’s Garden Foundation Initiative in Precision Oncology. The investigators reported financial relationships with Mylan, Atara Biotherapeutics, Chugai Pharma, Boehringer Ingelheim, and others.

Citation:

Feit et al. JAMA Oncol. 2019 Feb 28. doi: 10.1001/jamaoncol.2018.7002.

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