Oncology Business Management

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-Guérin therapy.

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.

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.

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.

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

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

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.

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.

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

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.

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.

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?

Marleen Meyers, MD, discusses rolapitant (Varubi), which the FDA recently approved to prevent delayed CINV.

Alectinib received an FDA priority review designation for patients with ALK-positive, locally advanced or metastatic non–small cell lung cancer (NSCLC) who have progressed or are intolerant to crizotinib (Xalkori).

The FDA has granted a priority review designation to the oral proteasome inhibitor ixazomib in combination with lenalidomide and dexamethasone as a treatment for patients with relapsed and/or refractory multiple myeloma.

Overregulation of new drug development has driven up the cost of care and resulted in significant loss of human life by delaying the approval of effective medications.

The first FDA-approved biosimilar, Zarxio, is now available for patients in the United States, following a series of lawsuits and court decisions.

The FDA has approved rolapitant (Varubi) for use in combination with other antiemetic agents to prevent delayed CINV.

The FDA has granted elotuzumab (Empliciti) a priority review for use in combination therapy in pretreated patients with multiple myeloma.

Cabozantinib (Cometriq) has received a breakthrough therapy designation from the FDA for the treatment of patients with advanced renal cell carcinoma following one prior therapy.

The FDA has granted a priority review to pembrolizumab (Keytruda) as a frontline treatment for patients with advanced melanoma.

The FDA has extended the review period for frontline nivolumab in patients with advanced melanoma by 3 months, to allow ample time to review additional data submitted by the PD-1 inhibitor's developer Bristol-Myers Squibb.

Many oncology practices have already made progress in adding appropriate personnel and implementing technology solutions, such as EHR, to enhance their ability to document and report care plans and patient event data. However, to be successful in meeting the specific criteria set forth in the OCM, most existing EHRs will need to be enhanced.

It may be too early to say whether EHRs have increased or decreased liability for physicians as a whole, but some say the technology generally reduces total medical errors and has no effect on insurance rates.

The FDA has assigned a priority review designation to the combination of dabrafenib and trametinib for patients with unresectable or metastatic BRAFV600 mutation-positive melanoma.