Abstract
A collection of recently published news items.
The Senate passed a bill that reauthorizes the FDA to collect fees from drug companies and medical device manufacturers for the next 5 years, money that accounts for more than a quarter of the agency's budget. The funds are used to help speed up the review of new agents and devices. Already approved by the House, the legislation will be sent to President Donald Trump for his signature.
Bristol-Myers Squibb announced that the FDA granted accelerated approval to nivolumab (Opdivo) for the treatment of certain patients with metastatic colorectal cancer—specifically, patients age 12 and older with mismatch repair–deficient and microsatellite instability–high disease that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
The U.S. Court of Appeals for the Federal Circuit ruled that a patent on bortezomib (Velcade; Takeda) is valid until 2022, preventing the launch of lower-cost generic versions by Teva Pharmaceuticals and other competitors. A lower court had ruled in favor of the generic drug makers in 2015, saying that the compound covered by the patent was “the inherent result of an obvious process.”
The Leukemia & Lymphoma Society announced the expansion of its Beat AML Master Trial, a precision medicine study launched last year to test investigational agents for the disease. Currently, four major pharmaceutical companies are providing the therapies, which are prescribed based on genetic markers.
The U.S. Preventive Services Task Force will continue to recommend against screening for ovarian cancer in asymptomatic women. The committee that developed the draft recommendation, available at www.uspreventiveservicestaskforce.org, found that screening does not reduce ovarian cancer deaths, and that it yields many false-positive results, which can lead to unnecessary surgery.
A nationwide survey of 1,000 adults commissioned by Research!America found that 86% of Americans say that health care providers should discuss clinical trials with patients diagnosed with a disease as part of their standard care.
For more news on cancer research, visit Cancer Discovery online at http://cancerdiscovery.aacrjournals.org/content/early/by/section.