AMAM - Ambrx Biopharma wins FDA fast track tag for prostate cancer therapy

2023-07-19 09:27:17 ET

Shares of Ambrx Biopharma ( NASDAQ: AMAM ) gained after the drug developer said that the FDA issued its Fast Track designation for the company's experimental antibody drug conjugate ARX517 for the treatment of patients with prostate cancer as a late-line option.

ARX517 is currently undergoing a U.S.-based Phase 1/2 trial called APEX-01 for patients with metastatic castration-resistant prostate cancer (mCRPC) who have received at least two FDA-approved therapies previously.

The FDA has issued the Fast Track designation for ARX517's use in mCRPC patients who have failed to respond to an androgen receptor pathway inhibitor. ARX517 is made up of a monoclonal antibody and a cancer cell-killing payload called pAF-AS269.

The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at serious conditions with unmet medical needs. It allows developers to have frequent communication with the regulator on plans for clinical studies.

Companies with Fast Track Designations can secure the FDA’s Accelerated Approval and Priority Review, subject to conditions, enabling patients to access those treatments sooner.

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