Oncology Business Management

Richard L. Schilsky, MD, from the University of Chicago Comprehensive Cancer Center, discusses sequestration and the effect on the FDA.

In the past year, clinical laboratories have begun determining the tumor mutational status of multiple genes simultaneously using next-generation sequencing platforms.

Craig L. Tendler, MD, Vice President, Late Development and Global Medical Affairs for Oncology, Janssen Oncology, discusses the importance of ibrutinib's Breakthrough Therapy Designation.

Ellen T. Matloff, MS, CGC, from the Yale School of Medicine/Yale Cancer Center, describes the impact of the US Supreme Court decision to restrict the patenting of segments of DNA in isolation.

Oncologist Jennifer Kelly, MD, PhD, shares her personal experiences as a stomach cancer patient, recognizes the barriers between cancer care providers and patients, and suggests ways of improving these interactions.

Dawn L. Hershman, MD, MS, discusses improving care and the use of compendia-approved oncology drugs.

Clinical pathway programs are evolving as a primary means by which payers intend to control drug utilization in cancer treatment.

Challenges remain regarding the mechanisms of docetaxel resistance, whether combination studies continue to make sense, and how the sequencing of docetaxel may impact toxicity and efficacy.

The FDA has rejected a new drug application for tivozanib for the treatment of advanced renal cell carcinoma, recommending an additional clinical trial to address concerns over existing clinical data.

Shortages of cancer drugs caused many oncologists and hematologists to choose suboptimal treatment plans for their patients last year, and government efforts have done little to boost the availability of the hard-to-find medications.

Richard Pazdur, MD, from the FDA's Center for Drug Evaluation and Research, emphasizes the importance of adequate data supporting proposals to the FDA for breakthrough therapy designations.

The FDA approved both dabrafenib and trametinib for the treatment of patients with metastatic or unresectable melanoma, as well as a companion diagnostic to properly identify the patients exhibiting the mutations that are targeted by these agents.