FDA OKs Novartis Prostate Cancer Treatment, Triples Eligible Patient Pool

The U.S. Food and Drug Administration (FDA) on Friday approved Novartis AG’s NVS Pluvicto for prostate cancer patients.

The expanded indication, which approximately triples the number of patients eligible to receive Pluvicto, is based on the Phase 3 PSMAfore trial results.

The patients have prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) and have been treated with an androgen receptor pathway inhibitor (ARPI) therapy.

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In the study, Pluvicto (lutetium Lu 177 vipivotide tetraxetan) reduced the risk of radiographic progression or death by 59% compared to a change in ARPI in patients with PSMA-positive mCRPC after treatment with ARPI therapy.

At an updated exploratory analysis, Pluvicto more than doubled median radiographic progression-free survival (11.6 months vs. 5.6 months).

In PSMAfore, the final overall survival (OS) analysis numerically favored Pluvicto, with a hazard ratio of 0.91, but was not statistically significant.

The OS analysis was confounded by the high rate of patients who crossed over from the control arm to Pluvicto (60.3%). When adjusted for crossover, the OS hazard ratio was 0.59.

Additional findings from the PSMAfore study showed Pluvicto demonstrated a consistent and favorable safety profile.

In March 2022, the FDA approved Pluvicto for adult patients with advanced PSMA-positive mCRPC that has spread to other body parts (metastatic).

These patients have already been treated with other anticancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy).

Novartis is investigating Pluvicto in earlier stages of the disease, including metastatic hormone-sensitive prostate cancer (PSMAddition) and oligometastatic prostate cancer (PSMA-DC).

Price Action: NVS stock is up 0.81% at $112.30 at the last check Friday.

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