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 Issues Complete Response Letter for CE-Melphalan in Myeloma

October 23rd 2015

The FDA issued a complete response letter to Spectrum Pharmaceuticals, informing the company that its new drug application (NDA) for the use of Captisol-enabled melphalan in multiple myeloma will not be approved in its current form.

Pazopanib's Activity in Thyroid Cancer Not Predicted by Thyroglobulin

October 22nd 2015

Pazopanib demonstrated significant clinical activity for patients with RAI-refractory differentiated thyroid cancer; however, a predictive biomarker for the therapy could not be uncovered.

FDA Approves Second-Line MM-398 Regimen for Metastatic Pancreatic Cancer

October 22nd 2015

The FDA has approved MM-398 (irinotecan liposome injection; Onivyde) in combination with 5-fluorouracil (5-FU) and leucovorin as a treatment for patients with metastatic pancreatic cancer following prior administration of a gemcitabine-based regimen.

FDA Grants Inotuzumab Ozogamicin Breakthrough Status for ALL

October 19th 2015

The FDA has granted the anti-CD22 antibody-drug conjugate inotuzumab ozogamicin a breakthrough therapy designation as a potential treatment for acute lymphoblastic leukemia.

OncLive Doubles Frequency of its Flagship Publication, OncologyLive

October 19th 2015

The nation's leading digital and print resource for oncology professionals, OncLive, announced today it is doubling the frequency of its flagship publication, OncologyLive, to keep pace with the quickly evolving oncology marketplace. Starting in January, the clinical news publication will publish twice a month, with expanded coverage of emerging therapeutic strategies and research developments.

OncLive Will Introduce Its New Peer-reviewed Journal, Contemporary Radiation Oncology, at ASTRO Meeting Oct. 18-21

October 15th 2015

OncLive, the nation's leading digital and print resource for oncology professionals, will introduce its new peer-reviewed journal, Contemporary Radiation Oncology, at the 57th annual meeting of the American Society of Radiation Oncology (ASTRO), which will be held October 18-21 in San Antonio, Texas.

FDA Grants Abemaciclib Breakthrough Status for Refractory Breast Cancer

October 8th 2015

The FDA has granted the CDK4/6 inhibitor abemaciclib a breakthrough therapy designation as monotherapy for heavily pretreated patients with refractory hormone-receptor-positive advanced breast cancer.

Guadecitabine Granted Orphan Designation for AML

October 6th 2015

The FDA has granted an orphan drug designation to the next-generation hypomethylating agent guadecitabine as a potential treatment for patients with acute myeloid leukemia.

FDA Schedules Advisory Meeting for MCNA in Bladder Cancer

October 2nd 2015

The FDA has scheduled an advisory hearing to discuss the biologics license application for the immunotherapy MCNA as a treatment for patients with high-risk non-muscle invasive bladder cancer following first-line bacillus Calmette-GuÃ©rin therapy.

FDA Approves Nivolumab/Ipilimumab Combination for BRAF Wild-Type Melanoma

October 1st 2015

The FDA has granted an accelerated approval to the combination of nivolumab and ipilimumab as a treatment for patients with BRAF V600 wild-type unresectable or metastatic melanoma.

Drug Shortages Persist Despite FDA Push for More Information

October 1st 2015

The door isn't fully closed on the acute oncology drug shortages of 4 years ago, observers say, though the FDA has established rules for greater disclosure by manufacturers and continues to tweak guidelines that would require far more information about manufacturing processes and production issues.

FDA Grants Priority Review to Eribulin for Soft Tissue Sarcoma

September 30th 2015

The FDA has granted a priority review designation to eribulin mesylate as a treatment for patients with soft tissue sarcoma following an anthracycline and at least one other regimen.

Research Leader Discusses FDA-Funded Immunotherapy for Head and Neck Cancer

September 29th 2015

Brett Miles, MD, DDS, discusses the potential of ADXS11-001 in HPV-associated head and neck cancer and other emerging therapies and treatment strategies.

Nivolumab Before Ipilimumab Has Greater Efficacy, Similar AEs

September 27th 2015

Two strategies of sequential immunotherapy for advanced melanoma showed similar safety and tolerability but substantially different efficacy.

FDA Awards Research Grants for 18 Rare Diseases, Including HPV-Related Oropharyngeal Cancer

September 22nd 2015

Eighteen new research grants, totaling more than $19 million, have been awarded by the FDA for product development in rare diseases such as HPV-related head and neck cancer and recurrent glioblastoma.

FDA Grants Priority Review to Maintenance Ofatumumab in CLL

September 21st 2015

The FDA has granted a priority review designation to ofatumumab as a maintenance therapy for patients with relapsed chronic lymphocytic leukemia following a response to second- or third-line therapy.

FDA Grants Nivolumab Breakthrough Designation in Renal Cell Carcinoma

September 16th 2015

Nivolumab (Opdivo) has received an FDA breakthrough therapy designation for the treatment of patients with advanced renal cell carcinoma.

340B Program Costs Exceed Earlier Estimates

September 15th 2015

Costs under the 340B program have ballooned far beyond earlier estimates, based on certain aspects of the program that have not been looked at closely.

FDA Approval Sought for Frontline Ibrutinib in CLL

September 14th 2015

A supplemental new drug application has been submitted for the BTK inhibitor ibrutinib (Imbruvica) as a therapy for treatment-naive patients with chronic lymphocytic leukemia who are over the age of 65.

Value-Based Care: Why Include Factors Beyond Oncologists' Control?

September 14th 2015

How can any analysis of the quality of cancer care being delivered by providers that focuses on a survival outcome as the ultimate measure of that quality-rather than on an evaluation of the optimization of the care process-be considered objectively valid and clinically meaningful?