On March 28, 2025, FDA approved the use of Pluvicto® before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer (mCRPC )patients who have previously been treated with androgen receptor pathway inhibitor (ARPI) therapy. A typical advanced prostate cancer therapy starts with Androgen receptor pathway inhibitor (ARPI) hormone therapy to slow cancer growth, followed by chemotherapy and radiation therapy. Many patients and their healthcare providers prefer to avoid or delay chemotherapy due to side effects; treatment guidelines also recommend avoiding the use of multiple ARPIs.
Per Novartis, the expanded use, based on the PSMAfore clinical trial data, approximately triples the number of patients eligible to receive Pluvicto. Based on the results, Pluvicto reduced the risk of radiographic progression or death by 59%, more than doubled the median radiographic progression-free survival to 11.6 months, and demonstrated a consistent and favorable safety profile.
In 2024, Pluvicto generated USD 1.39 billion in sales.
The approval is expected to change treatment paradigms for mCRPC, allowing for earlier use of a targeted therapy with potential benefits over a second ARPI.
In essence, the expanded indication for Pluvicto offers a potentially more effective and less toxic alternative to standard treatment strategies for a larger population of mCRPC patients.
