Articles related to DEVICE/DRUG APPROVALS

In comparison to 72% of patients who received placebo, 45% of those who received teplizumab-mzwv (Tzield, Provention Bio) over the course of a median follow-up of 51 months were found to have stage 3 type 1 diabetes. Teplizumab-mzwv appeared to delay the onset of type 1 diabetes by about two years, as the median time from randomization to diagnosis of stage 3 diabetes was 50 months in the teplizumab-mzwv group and 25 months in the placebo group.

Although the panel voted 16:1 for the new budesonide + albuterol inhaler in adults, they said the data does not support use in children and they were split on use in adolescents over the age of 12.

Anakinra (Kineret, Sobi) currently approved for rheumatoid arthritis and some rare disorders, was granted an emergency use authorization for a subgroup of COVID-hospitalized patients who are at risk of severe respiratory failure.

This approval was based on findings from the open-label, randomized, multicenter POSEIDON trial, which compared data from two of the study’s three treatment arms. When compared to patients in the other treatment arm, patients in this group had a significantly improved OS, with a median OS of 14 months as opposed to 11.7 months.

The approval for the treatment of pediatric patients aged 2 years and older with previously untreated high-risk classic Hodgkin lymphoma (HL) was based on the AHOD1331 phase 3 study, which examined the effects of brentuximab vedotin (Adcetris, Seagen) in combination with the dose-intensive chemotherapy regimen AVE-PC (doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide). Results showed that patients who received the AVE-PC combination had better event-free survival than those who received ABVE-PC (doxorubicin, bleomycin, vincristine, etoposide, prednisone and cyclophosphamide). Patients experienced a 59% decrease in their risk of death, second cancer, or disease progression.

Mikkael A. Sekeres, MD, currently Chief of the Division of Hematology at the Sylvester Comprehensive Cancer Center at the University of Miami, worked on the decision to remove Avastin’s indication for the treatment of HER2-negative metastatic breast cancer in 2008. As a result of the hearing, Dr. Sekeres poses the following question in his most recent book, Drugs and the FDA: Safety, Efficacy, and the Public’s Trust: “Had the FDA made a mistake in initially approving the drug?” Dr. Sekeres discussed with OBR the rise of accelerated approvals, progression-free survival as an endpoint, and the consequences of the Avastin hearing.