Richard Pazdur

TL;DR: The most common adverse reactions observed in the lenvatinib-treated patients were hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, decreased weight, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, and dysphonia.

TL;DR: Uridine triacetate is not recommended for the nonemergent treatment of adverse reactions associated with fluorouracil or capecitabine because it may diminish the efficacy of these drugs, and the safety and efficacy of uridine Triacetate initiated more than 96 hours following the end of administration ofThese drugs has not been established.

TL;DR: The FDA-approved entrectinib on August 15, 2019, for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

TL;DR: The FDA's draft PRO guidance describes principles that have been used in anticancer product approvals for more than a decade and encourages sponsors to consult with the FDA early in the process of PRO development.

TL;DR: In this paper , the authors provide an introduction to the concepts of external control in oncology trials, followed by a review of relevant and current research on this topic, and also focus on general considerations for designing a trial that may incorporate external control data.