Oncology Business Management | Specialty

The OncLive Oncology Business Management condition center page is a comprehensive resource for news and expert insights on business-focused updates and topics in oncology practices, including diversity efforts, telehealth, gaps in care, payment models, and more. This page features news articles, interviews in written and video format, and podcasts that focus on updates and best practices with oncology business management.

FDA Grants Priority Review to Durvalumab in Bladder Cancer

December 10th 2016

The FDA has granted a priority review to a biologics license application for the PD-L1 inhibitor durvalumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed on standard platinum‑based chemotherapy.

Cures Act Moves Step Closer to Adoption With Senate Approval

December 8th 2016

The sweeping, $6.3 billion 21st Century Cures Act, designed to create a 10-year pool of money for precision medicine development and social health initiatives, gained overwhelming Senate approval Wednesday and goes next to President Obama, who has said he will sign the bill.

Humana CEO Cheers for Risk-based Models

December 5th 2016

Value-based reforms from CMS have been received like extra work at the end of a long hard day. It hasn’t helped that making the leap to patient-centered care has involved grappling with a new set of quality metrics and wringing higher levels of performance out of electronic health reporting systems.

Dr. Berk on the Role of Hospitals Versus Independents

December 2nd 2016

As insurers and the federal government look for ways to reduce costs in oncology, the division of care between large, academic institutions and smaller providers is undergoing a process of change, says Seth Berk, MD, chair of the Financial Audit Committee for Regional Cancer Care Associates (RCCA) and a Mount Holly, New Jersey, specialist in internal medicine, hematology and oncology.

Passed by House, 21st Century Cures Act Could Spur Advances, Weaken FDA

December 2nd 2016

Viewed by some as a boon for precision medicine, an Alzheimer’s cure, brain research, and opioid abuse prevention, but also seen as weakening the FDA’s regulatory power, the $6.3 billion 21st Century Cures Act passed overwhelmingly in the House Wednesday by a vote of 392-26.

FDA Grants Pembrolizumab Priority Review for Hodgkin Lymphoma

December 1st 2016

The FDA has granted a priority review to a supplemental biologics license application for pembrolizumab for use as a treatment for patients with refractory classical Hodgkin lymphoma or those who have relapsed after ≥3 lines of therapy,

Challenging "What We Think We Know"

November 29th 2016

One of the basic tenets of science is the concept that all accepted “truths” are subject to objective testing and, through this process, can be shown to be false.

FDA Grants Ponatinib Full Approval for Rare Leukemias

November 29th 2016

The FDA has granted a full approval and label update to ponatinib for patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor therapy is indicated, as well as for patients with T315I-positive CML or T315I-positive Ph+ ALL.

FDA Grants Priority Review to Pembrolizumab for MSI-H Cancer

November 29th 2016

The FDA has granted a priority review to a supplemental biologics license application for pembrolizumab for previously treated patients with advanced microsatellite instability-high cancer.

Chasing Value Through an Imperfect Lens

November 25th 2016

We all know that healthcare is at a crossroads: to the left, there is rationed care, and to the right, you have economic insolvency, if we remain on our current course.

COA Declares Early Victory in CMS Part B Payment Battle

November 24th 2016

The change of administrations in Washington, DC may undermine the future of a proposal to revise Medicare Part B drug compensation, a plan that has been widely criticized in the oncological community because of the potential reduction in profit margins it entails.

When Well-Meaning Health Policy Goes Awry

November 23rd 2016

Those responsible for developing and implementing governmental health policy have an extremely difficult job. Not only do they have to attempt to satisfy often highly unrealistic expectations of legislators for overall goals and timelines, but they also are frequently asked to accomplish a task with woefully inadequate funding.

Expert Discusses the Future of Circulating Biomarkers in Prostate Cancer

November 23rd 2016

Biomarkers play a key role in the optimization of treatments for patients with prostate cancer. According to Mark Stein, MD, they can even serve as clinical endpoints in trials.

Looming Questions, Challenges Facing Physicians in Prostate Cancer

November 22nd 2016

Identifying biomarkers to determine who should receive chemotherapy, targeted agents, and immunotherapy is just one of several obstacles the prostate cancer community is currently facing.

Biomarkers, Combo Regimens Key to Mitigating AR-Resistance in mCRPC

November 21st 2016

A number of clinical trials are seeking to identify beneficial therapeutic outcomes in patients with prostate cancer who are resistant to androgen receptor–targeted agents.

New Guidelines Establish Recommendations for HER2 Testing for GEA

November 21st 2016

An expert panel has issued a set of guidelines for patients with gastroesophageal adenocarcinoma, recommending that they be tested for HER2 status before initiation of targeted therapy.

FDA Issues Complete Response Letter for Apaziquone in Bladder Cancer

November 19th 2016

The FDA has issued a complete response letter to Spectrum Pharmaceuticals informing the company that its new drug application for apaziquone in bladder cancer would not be approved.

Biomarker Development Key to Optimizing Immunotherapy in Lung Cancer

November 17th 2016

The expression of PD-L1 has been at the forefront of biomarker development for PD-1/PD-L1 inhibitors, but there is much uncertainty surrounding its use and other biomarkers are needed.

Dr. Goldberg on PD-L1 as a Biomarker in Lung Cancer

November 17th 2016

Sarah B. Goldberg, MD, MPH, assistant professor of Medicine, Yale Cancer Center, discusses the use of PD-L1 as a biomarker in treating patients with lung cancer.

Dual Biomarker Signature Holds Predictive Promise for Response to Anti-PD-L1 Therapy in NSCLC

November 16th 2016

Recent research suggests that the presence of PD-L1–positive and CD8+ cells may be useful for predicting responses in patients with non-small cell lung cancer who have been treated with durvalumab.