Articles

Holding what was essentially a one-person debate, Michael B. Atkins, MD, Deputy Director of the Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC, described strong cases for immunotherapy or molecularly targeted therapy as initial treatment for patients with advanced BRAF mutation–positive melanoma.

When combined with other clinically relevant parameters, a novel protein biomarker called IsoPSA can improve selection of patients with prostate cancer for biopsy. IsoPSA holds promise for improved diagnostic accuracy, said Eric A. Klein, MD, Chairman, Glickman Urological and Kidney Institute, Cleveland Clinic, OH, at the 2016 American Urological Association annual meeting.

A new article by a New York surgical team confirms that there is a survival benefit from an emerging therapy for difficult-to-treat soft-tissue tumors, but that it is not without a steep price for some patients.

On April 25, 2016, an FDA advisory committee voted not to recommend the approval of eteplirsen, an experimental drug that targets one of many genetic mutations causing Duchenne muscular dystrophy (DMD), a deadly degenerative disease that has no cure. After agreeing to study the real-world effects of eteplir­sen, the FDA advisory committee rejected findings that patients who have been taking eteplirsen since 2011 were still able to walk because the clinical data did not meet the FDA requirements for a well-controlled study.

In the United States, the standard of care for locally advanced bladder cancer after radical cystectomy is to “consider” adjuvant chemotherapy and ad­juvant radiation. Results of a 3-arm randomized clinical trial showed that adjuvant radiation therapy alone or combined with chemotherapy (ie, chemoradiotherapy) did not significantly improve disease-free survival compared with adjuvant chemotherapy alone. However, the findings hint at benefits for chemoradiotherapy that should be studied further. Brian Baumann, MD, a radiation oncology resident at the University of Pennsylvania, Philadelphia, presented the findings at the 2016 Genitourinary Cancers Symposium.

High-risk patients with metastatic renal-cell carcinoma (RCC) and venous tumor thrombus derived no benefit from cytoreductive nephrectomy and should be evaluated for clinical trials of systemic therapy, suggested a retrospective multicenter review.

The Individual Patient Expanded Access Application, which is designed to streamline the application procedure for individual patients who apply for expanded access to investigational therapeutics, including expanded access to drugs that are not in clinical trials, was recently updated by the FDA. Form FDA 3926 authorizes expanded access to investigational drugs for patients with serious or life-threatening conditions who have no therapeutic options.

Opposition to proposed changes to the Medicare Part B payment for prescription drugs continues to grow since the Centers for Medicare & Medicaid Services (CMS) announced its plan in March 2016.