FDA Grants Arvinas’ ARV-110 Fast Track Designation for mCRPC

FDA Grants Arvinas’ ARV-110 Fast Track Designation for mCRPC
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Arvinas' lead protein degrader ARV-110 to treat patients with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed after at least two prior therapies, the company announced. Therapies that target the androgen receptor, such as Zytiga (abiraterone) or Xtandi (enzalutamide) are the standard of care for prostate cancer. However, patients with mCRPC become resistant to these therapies, mostly because they produce increased amounts of the receptor or mutated versions that are not recognized by traditional treatments. Arvinas is a biopharmaceutical company that focuses on creating new therapies that neutralize disease-causing proteins. To do so, it developed the PROTAC protein degradation platform, a system that can mark any protein for degradation by the cell's natural mechanisms. ARV-110 is an oral treatment that targets all variants of the androgen receptor for degradation and therefore has the potential to successfully treat mCRPC patients. “While great strides have been made in the treatment of men with metastatic castration-resistant prostate cancer, current [androgen receptor]-targeted standard-of-care treatments are less effective in patients whose disease includes increased levels of androgen production or mutations in the androgen receptor,” John Houston, PhD, president and CEO of Arvinas, said
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