FDA grants Imfinzi priority review and Breakthrough Therapy designation for limited-stage SCLC

FDA approved Padcev (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, plus the PD-1 inhibitor Keytruda (pembrolizumab) or Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph), as neoadjuvant and adjuvant treatment for adult patients with muscle-invasive bladder cancer, regardless of cisplatin eligibility. 

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.