FDA Aims For Swifter Approvals Of Cancer Drugs With ‘Outsized’ Promise: Gottlieb
“We’re going to see more such cases, where a new drug offers an outsized survival benefit in a selected population of patients in a smaller, early-stage clinical trial," Food and Drug Administration commissioner Scott Gottlieb tells a House panel during a hearing on the 21st Century Cures Act.
The Wall Street Journal:
FDA To Allow Quicker Approval Of Some Promising Cancer Drugs
The Food and Drug Administration plans to allow quick approval of some cancer drugs if they show early and “outsized” survival benefits for patients even in small studies, the FDA’s commissioner said Thursday. Scott Gottlieb told the House Energy and Commerce subcommittee on health that the agency expects to see this situation more, given the advent of drugs that precisely target the genetic underpinnings of diseases. (Burton, 11/30)
Stat:
Gottlieb Signals Support For Both ‘Gold Standard’ And Expedited Review For Drug Approvals
Regulatory standards for some clinical trials may soon slacken, per a new statement from Food and Drug Administration Commissioner Scott Gottlieb. And though his words are vague, they’ve been enough to raise red flags in some corners. Testifying today before a Congressional committee on the 21st Century Cures Act, Gottlieb sent a mixed message: He wants the agency to “remain steadfast to our gold standard for safety and efficacy,” while making the development of breakthrough products “more scientifically modern and efficient, to meet the urgent needs of patients.” (Keshavan, 11/30)
In other agency news —
Boston Globe:
FDA Approves Foundation Medicine’s Cancer Gene Test
Federal regulators Thursday approved a diagnostic test by Cambridge-based Foundation Medicine Inc. that company leaders say will enable them to sequence the DNA of different cancer tumors to tailor treatments. The Food and Drug Administration approved the test, called FoundationOne CDx, which can detect all four classes of alterations in 324 cancer-related genes that cause solid tumors. (Saltzman, 11/30)
