From: .onclive.com The FDA has granted fast track designation to ETX-19477 for the treatment of adult patients with BRCA-mutated, hormone receptor (HR)–positive, HER2-negative unresectable or metastatic breast cancer.1 ETX-19477 is an oral, potent, and selective inhibitor of poly(ADP-ribose) glycohydrolase (PARG), is being evaluated as monotherapy in the phase 1/2 ERADIC8 trial (NCT06395519), which is enrolling phase 2 cohorts of patients …
FDA Fast Tracks Emiltatug Ledadotin in Advanced/Metastatic Breast Cancer
By: Jordyn Sava From: targetedonc.com The FDA has granted a new fast track designation to emiltatug ledadotin for the treatment of advanced or metastatic breast cancer, specifically targeting patients with HER2-low or HER2-negative disease, including TNBC.1 This designation applies to patients who have previously received a topoisomerase-1 inhibitor antibody-drug conjugate (ADC). Additionally, hormone-receptor positive patients must have either received prior …
FDA Grants Fast Track Status to AC699 for ER+/HER2–, ESR1-Mutated Breast Cancer
By: Kristi Rosa From:.onclive.com The FDA has awarded fast track designation to the investigation of AC699 as a potential therapeutic option for patients with estrogen receptor (ER)–positive, HER2-negative, ESR1-mutated, advanced or metastatic breast cancer that progressed on or following 1 more lines of endocrine-based therapy.1 The orally bioavailable, chimeric ERα degrader is designed to bring an ER ligand to cereblon …
BriaCell Receives FDA Fast Track Approval for Targeted Breast Cancer Immunotherapy
Source: BriaCell Therapeutics Corp. From:yahoo.com BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to BriaCell’s lead candidate, Bria-IMT™, for the treatment of metastatic breast cancer (breast cancer that has spread beyond the …