FDA approved Revtorpyk (gedatolisib) for the treatment of patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Revtorpyk is the only inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 to receive FDA approval.
FDA has released a final guidance for drug sponsors conducting clinical trials of psychedelics, including psilocybin, LSD, and MDMA, for the treatment of psychiatric and substance abuse disorders.
