Oncology Business Management | Specialty

FDA Updates Pomalidomide Multiple Myeloma Label

April 24th 2015

The FDA has updated the label for pomalidomide plus low-dose dexamethasone for multiple myeloma to include data from the phase III MM-003 study.

Crizotinib Granted Breakthrough Designation for ROS1-positive NSCLC

April 21st 2015

The FDA has granted a breakthrough therapy designation to crizotinib as a potential treatment for patients with ROS1-positive non–small cell lung cancer.

Recent FDA Approval of Ovarian Cancer Treatment Is Too Restrictive, Specialist in Gynecologic Malignancies Says in OncLive Article

April 20th 2015

The president of Medicine & Science at Cancer Treatment Centers of America and editor-in-chief of OncologyLive magazine argues the FDA's recent approval of olaparib (Lynparza) for women with BRCA-mutated advanced ovarian cancer is too restrictive and should be offered to many more patients.

Cabozantinib in RCC, Cost of Cancer Care, SGR Repeal, and More

April 17th 2015

Obama Signs SGR Repeal, Heralding New Era in Medicare Reimbursement

April 16th 2015

With the flourish of a pen, President Obama put an end to a yearly nightmare of congressional budget wrangling when he signed the Medical Access and CHIP Reauthorization Act of 2015, otherwise known as the Sustainable Growth Rate formula repeal.

Senate Joins House in SGR Repeal

April 15th 2015

The Senate has joined the House of Representatives in passing legislation to repeal the Sustainable Growth Rate (SGR) formula and replace it with the Medicare Access and CHIP Reauthorization Act of 2015 (HR 2).

CMS Starts Cutting Pay for Doctors Who Don't Measure Up

April 14th 2015

The new Value-Based Payment Modifier program from the Centers for Medicare & Medicaid Services may not be high on the list of concerns for the average oncologist, but its impact could be huge.

Bankruptcy Fears Burden Cancer Patients

April 9th 2015

The possibility of going bankrupt is high on the list of concerns for 37.1% of cancer patients.

Rucaparib Receives Breakthrough Designation for BRCA-Positive Advanced Ovarian Cancer

April 6th 2015

The FDA has granted a breakthrough therapy designation to rucaparib as a treatment for women with BRCA-mutated advanced ovarian cancer who have received at least two prior lines of platinum-based chemotherapy.

Internal Investigations May be Open to Court and Government Agency Scrutiny

April 4th 2015

Given a handful of recent cases, and a recent update to the CMS Voluntary Self-Referral Disclosure Protocol, it appears that the federal government may be using the existence of these audits as a means for demonstrating that the provider "knew or should have known" that fraud occurred.

ACA's High-Deductible Plans Cause Headaches, Hurt Patient Care

April 2nd 2015

The growing popularity of high-deductible health insurance plans has created a range of increasing pressures on oncologists and hematologists.

FDA Approves New Oral Formulation of Deferasirox

March 31st 2015

The FDA has granted an accelerated approval to an oral formulation of deferasirox (Jadenu) for the treatment of patients aged 2 and older with chronic iron overload due to multiple blood transfusions.

FDA Approves Abiraterone Pre-Chemo mCRPC Label Update

March 30th 2015

The FDA has updated the label for abiraterone acetate plus prednisone to include significant overall survival data from the final analysis of the phase III COU-AA-302 study.

FDA Priority Review Granted to Carfilzomib sNDA in Myeloma

March 30th 2015

An sNDA for the full approval of carfilzomib (Kyprolis) as a treatment for patients with relapsed multiple myeloma has been granted a priority review by the FDA.

Patricia Hofstra on Alternatives to Acquisition in Healthcare

March 25th 2015

Patricia Hofstra, attorney, Duane Morris, discusses options that independent oncology groups have other than being acquired by larger healthcare or oncology systems.

Report Calls for Drug Pricing Reforms

March 16th 2015

A new report has called for broad changes in the way drugs are priced in the United States, saying the law of supply and demand is not doing an effective job of bringing the cost of cancer drugs down to a level comparable with other countries.

FDA Approves Dinutuximab for High-Risk Neuroblastoma

March 10th 2015

The FDA has approved dinutuximab in combination with interleukin-2, GM-CSF, and 13-cis-retinoic acid as a frontline therapy for pediatric patients with high-risk neuroblastoma.

FDA Approves Zarxio as First US Biosimilar

March 6th 2015

The FDA has approved its first biosimilar, Zarxio, for all five its counterpart Neupogen's authorized indications.

FDA Approves Nivolumab for Lung Cancer

March 4th 2015

Acting 3 months ahead of schedule, the FDA approved nivolumab (Odivo) for patients with squamous non-small cell lung cancer.

FDA Grants Rindopepimut Breakthrough Designation for EGFRvIII-Positive Glioblastoma

February 23rd 2015

Rindopepimut (Rintega) has gained a Breakthrough Therapy Designation from the FDA to treat adult patients with glioblastoma multiforme that test positive for the epidermal growth factor receptor variant.