FDA has issued a draft guidance document, “Evaluating Cancer Drugs in Patients with Central Nervous System MetastasesExternal Link Disclaimer,” which, if finalized, would provide recommendations to sponsors designing clinical trials of drugs and biological products that are intended to support product labeling describing anti-tumor (preventing or inhibiting the formation or growth of tumors) activity in patients with central nervous system metastases from solid tumors originating outside the CNS.
On Feb. 2, Nature Medicine published the results of a large, randomized, prospective clinical trial in the nascent and some say, fringe, field of chrono-oncology—the study of how natural biological rhythms might impact cancer outcomes.
