Articles related to FDA

An FDA expert panel voted 16-0, with one abstention, recommending that future FDA approvals of PI3K inhibitors be supported by randomized data. The four currently-approved PI3K inhibitors for treating hematologic malignancies received FDA approval based on single-arm data. Although these drugs have offered durable ORR and improvements in PFS, randomized data presented at the hearing showed they are associated with higher rates of serious adverse events, including fatality.

The US Food and Drug Administration (FDA) has said “no” to Akebia Therapeutics’ drug application for vadadustat, a therapy to treat anemia due to chronic kidney disease. Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. The FDA cited safety concerns as the main reason for it rejecting the application.

The FDA has withdrawn its authorization for use of the monoclonal antibody sotrovimab in the treatment of COVID-19 in regions with a high frequency of the Omicron BA.2 subvariant. Data show that the authorized dose of the monoclonal antibody — 500 mg — is unlikely to be effective against the BA.2 COVID-19 subvariant.

Orexin receptor antagonists work by suppressing the wake drive through blocking wake-promoting neuropeptides. Daridorexant is the third dual-orexin inhibitor to receive FDA approval for people with difficulty in sleep onset or sleep maintenance.

Illucix is a preparation kit for gallium-68 PSMA-11 injection, an agent indicated for PET PSMA position tumors in patients with suspected prostate cancer metastasis who are eligible for initial definitive therapy and have suspected cancer recurrence based on elevated PSA levels.

A “breakthrough therapy” designation has been granted by the FDA to CLN-081 for the treatment of a subset of non-small cell lung cancer. The designation applies to use of the agent by patients with locally advanced or metastatic EGFR-mutated NSCLC who previously received chemotherapy and comes as a phase 1/phase 2a clinical trial is underway.