Web Exclusives

Approvals for new delivery methods for Herceptin and Cinvanti, and a new indication for Lonsurf close out the month of February in the FDA’s oncology-related activity.

A dizzying array of new chimeric antigen receptor (CAR) T-cell therapies targeting the B-cell maturation antigen (BCMA) designed specifically for the treatment of multiple myeloma was presented at the 2018 American Society of Hematology (ASH) annual meeting. BCMA-targeted CAR T-cell therapies are designed to improve T-cell persistence, depth of response, and tolerability. Response rates reported at ASH 2018 range from 70% to 100%, depending on the patient population and the use of previous regimens.

On February 15, 2019, the US Food and Drug Administration (FDA) approved the immunotherapy agent pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with resected stage III melanoma. This was the fourth approval pembrolizumab has received in the United States for the treatment of skin cancer, and the first FDA approval in the adjuvant setting.

On February 12, 2019, the US Food and Drug Administration (FDA) granted approval for daratumumab (Darzalex; Janssen), a CD38-directed antibody, to be given in a split-dosing regimen to patients with multiple myeloma (MM). Darzalex is the first and only CD38-directed antibody to receive regulatory approval for the treatment of patients with MM and is the first to be approved for the split-dosing regimen. This new regimen gives patients and healthcare providers the option to split the first dose of Darzalex over the course of 2 consecutive days, which has the benefit of shortening the duration of the first infusion.

San Diego, CA—In patients with multiple myeloma (MM), the use of drug therapy as maintenance has been shown to prolong the length of time the disease is controlled. Specifically, use of maintenance therapy may affect overall survival, particularly when it is used after an autologous stem-cell transplant (ASCT).

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 posted on its website a notice alerting the public of its current operational status.

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.