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 in a press release.

“We believe, due to its ability to iteratively degrade the AR protein, ARV-110 could represent a meaningful new therapy to improve the lives of patients battling mCRPC, and for whom current therapies are not effective. The Fast Track designation by the FDA recognizes the urgency for improved treatments for these patients,” he said.

ARV-110 showed promising results in preclinical studies by significantly reducing the amount of androgen receptor in several prostate cancer cell lines. It also significantly inhibited tumor growth in a mouse model of prostate cancer resistant to standard therapies.

Arvinas is recruiting patients in the U.S. for its Phase 1 clinical trial (NCT03888612) assessing the safety and tolerability of ARV-110 in men with mCRPC whose disease progressed after treatment with at least two standard therapies. Preliminary results are expected this year.

By receiving the Fast Track designation, Arvinas can have more frequent meetings with the FDA to discuss the development plan for ARV-110. The treatment is also considered for accelerated approval.