September 25, 2022

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FDA approved Novartis targeted radioligand therapy Pluvicto for prostate cancer

FDA approved Novartis targeted radioligand therapy Pluvicto for prostate cancer



 

FDA approved Novartis targeted radioligand therapy Pluvicto for prostate cancer.


Novartis announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s targeted radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan, formerly known as 177Lu-PSMA-617) for the treatment of prostate-specific membrane antigen (PSMA). ) in patients with metastatic castration-resistant prostate cancer (mCRPC).

They had been treated with taxane-based chemotherapy and androgen receptor signaling pathway inhibitors.

The press release notes that Pluvicto is the first FDA-approved targeted radioligand therapy for the treatment of this type of mCRPC patient. It combines isotope therapy with targeted compounds.

 

In recent years, radiopharmaceuticals have become an important direction in the field of precision tumor therapy.

Novartis’ Pluvicto links small-molecule compounds that bind PSMA to radioisotopes. It binds to PSMA-expressing prostate cancer cells, and the radiation energy released by the radioisotope damages the tumor cells, triggering cell death.

PSMA is highly expressed in more than 80% of prostate cancer patients. Because the radiation released by Pluvicto only works over a short distance, the drug’s damage to surrounding healthy cells is limited.

The therapy was previously granted Breakthrough Therapy Designation by the FDA, and its New Drug Application was granted Priority Review status by the FDA.

 

FDA approved Novartis targeted radioligand therapy Pluvicto for prostate cancer

Introduction to Pluvicto (177Lu-PSMA-617) therapy (Image source: Novartis official website)

 

This approval is based on positive results from a pivotal Phase 3 clinical trial.

Trial results showed that the addition of Pluvicto reduced the risk of death by 38% compared to standard treatment, and Pluvicto also significantly reduced the risk of radiological disease progression or death.

Furthermore, among patients with evaluable disease at baseline, the overall response rate was 30% in the Pluvicto group and 2% in the standard-therapy control group.

 

 

 

 

 

 

 

References:

[1] Novartis PluvictoTM approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer. Retrieved March 23, 2022, from https://www.globenewswire.com/news-release/2022/ 03/23/2408996/0/en/Novartis-PluvictoTM-approved-by-FDA-as-first-targeted-radioligand-therapy-for-treatment-of-progressive-PSMA-positive-metastatic-castration-resistant-prostate- cancer.html

[2] Pluvicto label. Retrieved March 23, 2022, from https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215833s000lbl.pdf

FDA approved Novartis targeted radioligand therapy Pluvicto for prostate cancer

(source:internet, reference only)


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