Web Exclusives

  • FDA Resumes Operations After Government Shutdown Ends
  • FDA Approves New Drug Indication for Use in Hepatocellular Carcinoma
  • FDA Approves Pembrolizumab for Merkel-Cell Carcinoma
Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, on indefinite hold.
The FDA recently approved 2 new biosimilars for managing different conditions related to cancer—epoetin alfa-epbx (Retacrit) is the first biosimilar to epoetin alfa (Epogen, Procrit) and pegfilgrastim-jmbd (Fulphila) is the first biosimilar to pegfilgrastim (Neulasta).
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.
The results of the phase 3 OPTIMISMM clinical trial showed a 39% risk reduction in disease progression or death with pomalidomide, bortezomib, and low-dose dexamethasone compared with bortezomib and low-dose dexamethasone alone.
The drug affordability ratings in the National Comprehensive Cancer Network 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.
The investigational LOXO-292, a potent and highly selective RET kinase inhibitor, has demonstrated robust and durable antitumor activity against RET-activating fusions and mutations, and has shown promising efficacy in patients with solid tumors and RET mutations.

The second-generation chimeric antigen receptor (CAR) T-cell therapy, bb2121, engineered to target B-cell maturation antigen, 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.

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.
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