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 Approves Single-Dose Fosaprepitant for CINV

February 4th 2016

The FDA approved single-dose fosaprepitant dimeglumine (Emend for injection) in combination with other antiemetic agents for the prevention of delayed chemotherapy-induced nausea and vomiting (CINV) following moderately emetogenic chemotherapy (MEC), according to Merck, the developer of the drug.

FDA Issues Complete Response Letter for Immunotherapy MCNA in Bladder Cancer

February 3rd 2016

The FDA issued a complete response letter to Telesta Therapeutics informing the company that its biologics license application for MCNA in bladder cancer would not be approved and that an additional phase III clinical trial was needed to adequately evaluate the immunotherapy.

FDA Grants Venetoclax Breakthrough Designation in AML

January 28th 2016

Venetoclax has received an FDA breakthrough therapy designation for use in combination with hypomethylating agents in treatment-naïve patients with acute myeloid leukemia who are not eligible for standard high-dose induction treatment.

FDA Grants Cabozantinib Priority Review for RCC

January 28th 2016

The FDA has granted a priority review designation to cabozantinib as a treatment for patients with advanced renal cell carcinoma following progression on one prior therapy.

FDA Approves Eribulin for Advanced Liposarcoma

January 28th 2016

The FDA has approved eribulin mesylate as a treatment for patients with advanced or unresectable liposarcoma following prior treatment with an anthracycline-based chemotherapy.

FDA Grants Olaparib Breakthrough Designation in mCRPC

January 28th 2016

Olaparib (Lynparza) has received an FDA breakthrough therapy designation as a treatment for patients with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer in those who have received a prior taxane-based chemotherapy and at least either hormonal agent enzalutamide (Xtandi) or abiraterone acetate (Zytiga).

Michael J. Hennessy Associates Launches The Institute for Value-Based Medicine to Translate Evidence-Based Research into Value-Based Decisions

January 27th 2016

Michael J. Hennessy Associates, Inc., a full-service health care communications company offering education, research and medical media, introduces The Institute for Value-Based Medicine, a comprehensive online source of timely data, information and perspectives related to value-based medicine.

FDA Expands Nivolumab's Frontline Melanoma Approval to Include BRAF-Mutant Patients

January 23rd 2016

The FDA has expanded the frontline melanoma indications for nivolumab as a single agent and in combination with ipilimumab to include patients with BRAF mutations.

FDA Grants Priority Review to Lenvatinib/Everolimus Combo for RCC

January 18th 2016

The FDA has granted a priority review designation to the combination of lenvatinib and everolimus as a treatment for patients with metastatic renal cell carcinoma following one prior VEGF-targeted therapy.

Lenvatinib/Everolimus Combo Submitted for Approval in Advanced RCC

January 15th 2016

Regulatory filings have been submitted in the United States and Europe for the combination of lenvatinib and everolimus as a treatment for patients with metastatic renal cell carcinoma following a VEGF-targeted therapy.

Clinical Decision Support Tools Deliver Benefits Beyond Improved Patient Care

January 14th 2016

One best practice identified for transforming quality, safety and efficiency in healthcare is the use of clinical decision support tools.

FDA Grants Venetoclax Priority Review in Second-Line CLL

January 12th 2016

The FDA has assigned a priority review to venetoclax for use in adults with chronic lymphocytic leukemia, including patients with a 17p deletion, following at least 1 prior therapy.

FDA Approves Alcohol-Free Docetaxel Formulation

December 28th 2015

The FDA has approved a non-alcohol formulation of docetaxel as a treatment for patients with breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

FDA Grants BI-1482694 Breakthrough Designation for T790M-Positive NSCLC

December 22nd 2015

The FDA has granted a breakthrough therapy designation to the third-generation EGFR TKI BI-1482694 as a potential treatment for patients with EGFR T790M-positive non–small cell lung cancer.

FDA Approves Two New Indications for Pembrolizumab in Advanced Melanoma

December 18th 2015

The FDA has expanded the approval for single-agent pembrolizumab to include the frontline treatment of patients with advanced melanoma regardless of BRAF status.

FDA Delays Decision on Rociletinib in NSCLC

December 16th 2015

The FDA has extended the review period for rociletinib in patients with EGFR T790M-positive non–small cell lung cancer by 3 months, to allow ample time to review additional data.

Indication-Specific Pricing Still a Long Way Off

December 14th 2015

Cancer drugs in the United States have increased 5- to 10-fold since 2000, but several analyses indicate that this increase in cost does not match improvements in health and overall survival.

FDA Approves Alectinib for ALK-Positive NSCLC

December 11th 2015

The FDA has granted an accelerated approval to alectinib as a treatment for patients with metastatic ALK-positive non–small cell lung cancer following progression on crizotinib.

Complications, Costs Higher With Mastectomy Versus Lumpectomy for Early Breast Cancer

December 10th 2015

The risk of complications from mastectomy plus reconstruction was increased by two-fold compared with lumpectomy plus whole breast irradiation, after adjustment for other treatment differences.

FDA Grants Priority Review to Palbociclib in Pretreated HR+/HER2- Breast Cancer

December 10th 2015

The FDA has granted a priority review to a supplemental new drug application for palbociclib (Ibrance) for use in combination with fulvestrant in pretreated patients with HR-positive, HER2-negative metastatic breast cancer.

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