Oncology Business Management

A supplemental biologics license application has been submitted to the FDA to expand the approval of blinatumomab (Blincyto) to include the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Obtaining quality cancer care in Alaska is often difficult and expensive owing to the sparse highway network and the scattered nature of the state’s population of 736,000 people, who are spread out over more than a half-million square miles.

The FDA has approved everolimus for the treatment of adult patients with progressive, well-differentiated non-functional, locally advanced or metastatic gastrointestinal or lung neuroendocrine tumors.

The FDA approved obinutuzumab (Gazyva) plus bendamustine followed by obinutuzumab alone for the treatment of patients with follicular lymphoma who were not responsive to a rituximab regimen, or who relapsed after rituximab-based therapy.

The FDA has accepted, for review, a supplemental new drug application for enzalutamide (Xtandi) capsules in patients with metastatic castration-resistant prostate cancer that includes findings from the head-to-head studies, TERRAIN and STRIVE.

The Hatch Waxman Act, established in 1984 to promote lower cost generics production, is deeply flawed and has contributed to the maintenance of high drug prices.

The FDA has granted midostaurin a breakthrough therapy designation as a potential treatment for adult patients with newly diagnosed FLT3-mutated acute myeloid leukemia.

The FDA has granted a breakthrough therapy designation to durvalumab as a treatment for patients with PD-L1–positive inoperable or metastatic urothelial bladder cancer following progression on prior treatment with a platinum-based regimen.

For one group of physicians in Seattle, hooking up with US Oncology seemed like a good idea at first, until circumstances changed and the deal no longer was a benefit for any of the partners.

The FDA has placed a full clinical hold on trials exploring pacritinib, following reports of patient deaths related to intracranial hemorrhage, cardiac failure, and cardiac arrest in the phase III PERSIST-2 trial.

Matthew Banegas, PhD, MPH, discusses a recent study that found that a considerable number of working-age adults who survive cancer and its toxic treatments, end up with substantial medical debts or declare bankruptcy.

The FDA has scheduled an ODAC advisory hearing for April 12, 2016, to discuss the new drug application for rociletinib as a treatment for patients with metastatic EGFR T790M-mutated non–small cell lung cancer.

Changes are brewing again in the direct-to-consumer genetic testing industry including developments with the potential to affect the public in the oncology field.

An affinity enhanced T-cell therapy has received an FDA breakthrough therapy designation for the treatment of patients with inoperable or metastatic pretreated synovial sarcoma who harbor HLA-A*201, HLA-A*205, or HLA-A*206 alleles and whose tumors express the NY-ESO-1 tumor antigen.

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.

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.

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.

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.

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

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, 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.

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.

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.

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.

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