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On May 15, 2018, the FDA approved epoetin alfa-epbx (Retacrit; Pfizer) as the first biosimilar to epo­etin alfa (Epogen, Procrit; Amgen) for the treatment of anemia caused by chronic kidney disease, myelosuppressive chemotherapy, or the use of zidovudine in patients with HIV. The new biosimilar is also approved to reduce the need for allogeneic red blood cell transfusions in patients at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery.

Once-weekly carfilzomib (Kyprolis) therapy at a higher dose significantly improved progression-free survival (PFS) and reduced the risk of disease progression or death compared with twice-weekly carfilzomib in patients with relapsed or refractory multiple myeloma. The overall safety profile for both regimens in the randomized phase 3 ARROW clinical trial were similar, said co-lead investigator María-Victoria Mateos, MD, PhD, Director, Myeloma Unit, University Hospital Salamanca-IBSAL, Spain, at the 2018 European Hematology Association Congress.

Chicago, IL—The triplet regimen of pomalidomide (Pomalyst), bortezomib (Velcade), and low-dose dexamethasone (PVd) significantly extended progression-free survival (PFS) compared with the doublet of bortezomib plus dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma who had previously received lenalidomide (Revlimid) therapy, according to new data presented at ASCO 2018.

Chicago, IL—The drug affordability rating in the National Comprehensive Cancer Network (NCCN) Evidence Blocks are inconsistent with real-world total episode of care costs, according to Scott D. Ramsey, MD, PhD, Director, Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, Seattle, WA. He presented the results of a recent analysis at ASCO 2018.

“These promising results underscore the importance of screening for these alterations in the clinic. The activity of LOXO-292 is durable, with over 90% of patients still on treatment as of the data cutoff,” said Alexander E. Drilon, MD.

Chicago, IL—The second-generation chimeric antigen receptor (CAR) T-cell therapy bb2121, engineered to target B-cell maturation antigen (BCMA), a protein on the surface of certain myeloma cells, displayed continuing efficacy and safety in an update of a phase 1 clinical trial in patients with relapsed or refractory multiple myeloma, according to data presented at ASCO 2018. Currently, no CAR T-cell therapy has been approved for patients with multiple myeloma.

Navigating through the oncology landscape has become increasingly challenging. As a result, it is imperative for oncology practices today to stay abreast of the changes occurring in the field to succeed.
In the FDA’s dynamic regulatory environment, the patient voice has been adopted and end points for clinical trials have evolved from overall survival to other efficacy measures. “Having multiple drugs is a good thing. Many are approved on nonsurvival end points, and they have transformed the diseases,” said Richard Pazdur, MD.
The NCCN’s first guideline for side effects from immunotherapy recognizes a new spectrum of events in patients who are receiving immune checkpoint inhibitor therapy.
“The wide range of potential immune-related adverse events requires multidisciplinary, collaborative management by providers across the clinical spectrum,” according to Michael A. Postow, MD, and colleagues.
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