US Food and Drug Administration (FDA) approvals in 3Q show no effect of the pandemic, with roughly the same number of approvals as in 3Q19. The agency granted three accelerated approvals for cancer indications, including two that target CD19 in unique ways (Gilead’s Tecartus, which has circulating malignant cells removed during manufacturing, and MorphoSys’s Monjuvi, which has modifications to the Fc portion). The first small-molecule exon-skipping drug, Roche’s Evrysdi, was approved. The saga of Biogen’s monoclonal aducanumab may finally come to a resolution in early 2021, when the FDA reviews data from its restarted continuation trial for Alzheimer’s disease. Both the European Medicines Agency (EMA) and FDA gave thumbs down to BioMarin’s hemophilia A drug valoctocogene roxaparvovec.
Drug/company | Indication | Drug information |
|---|
TT11 CD30 CAR-T/Tessa Therapeutics | Hodgkin’s lymphoma | 7/23/2020 In a phase1/2 trial of CAR-T cells against CD-30 in heavily pretreated patients, 59% had complete response, 72% had overall response (J. Clin. Oncol. https://doi.org/10.1200/JCO.20.01342, 2020) |
Nemolizumab/Galderma | Atopic dermatitis | 7/9/2020 In a phase 3 double-blind placebo controlled trial of this subcutaneous human monoclonal against IL-31AR, patients receiving the drug experienced greater reduction in pruritus than those receiving placebo (N. Engl. J. Med. 383, 141–150, 2020) |
Veklury (remdesivir)/Gilead Sciences | COVID-19 | 8/21/2020 Patients randomized to a 5-day course of remdesivir had a statistically significant difference in clinical status compared with standard care (JAMA https://doi.org/10.1001/jama.2020.16349, 2020) |
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