FDA Approves Novartis' Pluvicto for Earlier Treatment of Prostate Cancer | iPharmaCenter
- ipharmaservices
- Apr 3
- 2 min read
The U.S. Food and Drug Administration (FDA) has granted approval for the expanded use of Pluvicto® (lutetium Lu 177 vipivotide tetraxetan), a radioligand therapy developed by Novartis, for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). This approval allows for its administration earlier in the treatment cycle, specifically after one androgen receptor pathway inhibitor (ARPI) and before chemotherapy, significantly increasing the number of eligible patients.
Clinical trial data from the Phase III PSMAfore study played a crucial role in securing this approval. Findings from the study revealed that Pluvicto reduced the risk of disease progression or death by 59% compared to patients who switched to an alternative ARPI. Additionally, median radiographic progression-free survival (rPFS) more than doubled, extending to 11.6 months from 5.6 months.
A major concern in mCRPC treatment is that nearly half of patients do not survive long enough to receive a second line of therapy. The ability to use Pluvicto earlier in the treatment process offers a promising option for improving patient outcomes while maintaining a well-tolerated safety profile. The most commonly reported side effects in the study included mild to moderate dry mouth (61%), fatigue (53%), nausea (32%), and constipation (22%).
Pluvicto functions as a targeted radioligand therapy (RLT), combining a specific targeting compound with a radioactive component, lutetium-177. When introduced into the bloodstream, it selectively binds to PSMA-expressing prostate cancer cells, emitting radiation that damages cancerous and nearby cells, thereby inhibiting their growth and survival.
This regulatory milestone makes Pluvicto the only PSMA-targeted treatment that has demonstrated significant improvements in rPFS for patients in both pre- and post-chemotherapy settings. Additionally, Novartis is actively investigating its potential in earlier stages of prostate cancer, including metastatic hormone-sensitive prostate cancer (PSMAddition trial) and oligometastatic prostate cancer (PSMA-DC trial).
To support the expanded use of Pluvicto, Novartis has reinforced its radioligand therapy manufacturing capacity in the U.S., ensuring the supply chain meets the increased demand and facilitating efficient patient access to treatment.
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