Next-generation sequencing is used with increasing frequency to provide essential information about a patient’s diagnosis and treatment. In recent months, the U.S. Food and Drug Administration (FDA) has approved several new next-generation sequencing diagnostic tools, and the Centers for Medicare & Medicaid Services (CMS) has issued a positive national coverage decision. Next-generation sequencing tests…
Friends of Cancer Research (Friends) recognized Senators Orrin Hatch (R–UT) and Michael Bennet (D–CO) for responding to a recently identified public health issue and proposing a solution to an issue impacting patients and their physicians. Senators Hatch and Bennet jointly introduced the Making Objective Drug Evidence Revisions for New Labeling Act, or MODERN Labeling Act.…
The Friends of Cancer Research (Friends) recently announced the launch of phase II of its tumor mutational burden Harmonization Project, as the research team finalizes data collected from phase I in silico analysis. “Recent data show a role for [tumor mutational burden] in identifying patients more likely to respond to immunotherapy,” said Jeffrey Allen,…
On July 9, 2012, officials signed the Food and Drug Administration Safety and Innovation Act (FDASIA) which had a section within it that established a new designation—the Breakthrough Therapy Designation—which allows for expedited development and review of drugs to treat serious or life-threatening diseases if substantial evidence is provided. The concept for the designation…
A bipartisan duo of senators wants to give the Food and Drug Administration the power to add off-label uses to certain generic drug labels. Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) introduced legislation late Thursday that would put in place new requirements on generic drug makers and FDA. Right now, drug makers…
Real-life studies have become increasingly important in the scientific world in recent years. Although they have numerous limitations, they have the advantage of better representing the population with which we normally have to deal in our everyday clinical practice. Randomised controlled trials (RCTs) remain the most effective form of evaluation of the efficacy of a…
The Oregon Health Authority is weighing a recommendation to deny Medicaid coverage for next-generation sequencing tests in the state. If enacted, Oregonians who rely on Medicaid for cancer treatment will not be offered coverage for NGS testing. Mainstream oncologists and experts on disparities in cancer care say that this first-of-its-kind anti-genetic-testing policy will create…
On August 8, ASCO and Friends of Cancer Research (Friends) submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO and Friends collaboration to broaden eligibility for participating in clinical trials by addressing…
Commissioner Scott Gottlieb is scaling up FDA efforts to assert control over laboratory developed tests, saying in a speech that the agency would take a flexible approach — but first needs the power to act. The FDA last month sent 59 pages of recommendations to lawmakers constructing a bill to regulate LDTs, the custom diagnostic…
FDA’s recent proposal to establish “a collaborative community” of stakeholders to support the agency in its decision-making process for diagnostics regulation could also serve as “a compelling new paradigm” for the cancer research community, Commissioner Scott Gottlieb said at a Friends of Cancer Research event Thursday (Sept. 13). In August, FDA floated what it…
