Web Exclusives

On April 27, 2017, the kinase inhibitor regorafenib (Stivarga; Bayer HealthCare) received a new indication from the FDA for the treatment of patients with hepatocellular carcinoma (HCC) who had previously received sorafenib.
On April 17, 2017, atezo­lizumab (Tecentriq; Genentech), a PD-L1–blocking antibody, received a new indication by the FDA as first-line treatment for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy.
On March 23, 2017, the FDA accelerated the approval of avelumab (Bavencio; EMD Serono/Pfizer), PD-L1–blocking antibody, for the treatment of adults and pediatric patients aged ≥12 years with metastatic Merkel-cell carcinoma.
“Maintenance therapy is an important part of a cancer treatment regimen for patients who have responded positively to a primary treatment,” said Richard Pazdur, MD, Acting Director of the FDA’s Center for Drug Evaluation and Research and Director of the FDA’s Oncology Center of Excellence. “Zejula offers patients a new treatment option that may help delay the future growth of these cancers, regardless of whether they have a specific genetic mutation,”
The FDA approved ribociclib, in combination with an aromatase inhibitor, for the treatment of postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer.
We wish to correct a potential misunderstanding of our findings as described in the article, as communicated by Gary Owens, MD, in the Stakeholder Perspective, “Important Insights from Real-World Treatment Patterns and Outcomes for Varicose Veins,” an opinion piece related to our article.
The 3-drug regimen should be considered a new standard of care. The 61% improvement in PFS is “unprecedented in randomized studies that compare novel treatments for relapsed or refractory multiple myeloma,” reported Antonio Palumbo, MD.
The first-in-class antibody-drug conjugate rovalpituzumab tesirine (Rova-T) may be a new treatment option for patients with small-cell lung cancer (SCLC), which has a very poor prognosis and few treatment options.
The influence of genetics on the risk for type 2 diabetes has been suggested by previous research, but new research from the NIH has now outlined in unprecedented detail the role of common genetic variants in the risk for this disease. “Our study has taken us to the most complete understanding yet of the genetic architecture of type 2 diabetes,” said Michael Boehnke, PhD.
While testifying before the Senate Committee on Finance on July 13, 2016, Acting Administrator for CMS Andrew Slavitt said that the agency would consider delaying the implementation of MACRA to address physician and stakeholder concerns. Signed into law in 2015, MACRA will dramatically change the way in which physicians caring for Medicare beneficiaries are paid. The final rule is expected to be released in November of 2016, with an intended start date of January 1, 2017.
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