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Sutro Biopharma Announces STRO-002 FDA Fast Track Designation for Patients with Advanced Ovarian Cancer
SOUTH SAN FRANCISCO, Calif., Aug. 18, 2021 /PRNewswire/ -- Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and
About this update from Sutro Biopharma, Inc.
[{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., Aug. 18, 2021 /PRNewswire/ -- Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for STRO-002, a folate receptor alpha (FolRα)-targeting antibody-drug conjugate (ADC), for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior lines of systemic therapy.\n\"We are pleased with the FDA's decision to grant Fast Track designation for STRO-002 and welcome the opportunity to have more frequent interactions with the agency,\" said Dr. Arturo Molina, Chief Medical Officer of Sutro Biopharma. \"We continue to be enthused by the potential of the STRO-002 program, which has shown encouraging preliminary activity and tolerability in our Phase 1 dose-escalation study in ovarian cancer, and plan to continue to work with the FDA to potentially accelerate our clinical and regulatory efforts.\"\nBill Newell, Chief Executive Officer of Sutro Biopharma added, \"Receiving Fast Track designation is an important recognition for STRO-002 as a potentially best-in-class FolRα ADC for women with ovarian cancer. We look forward to further collaboration with the FDA to bring this potentially important therapeutic option to women in advanced stages of their disease with limited treatment options.\" \nAbout Fast Track Designation\nThe FDA's Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions or life-threatening conditions and demonstrate the potential to address an unmet medical need. A drug candidate that receives Fast Track designation can expect more frequent interaction with the FDA to discuss the drug candidate's development plan, the potential for accelerated approval, and the possibility of priority review, if relevant criteria are met at the time of submission of a Biologic Licensing Application (BLA). \nAbout STRO-002 Clinical Development\nSTRO-001-GM1 is a Phase 1 trial for STRO-002 for patients with advanced ovarian cancer that have progressed or relapsed afte...