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▎WuXi AppTec Content Team Editor Today, Novartis announced that the U.
S.
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)-positive metastatic castration-resistant prostate cancer (mCRPC) patients
.
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
.
▲Pluvicto (177Lu-PSMA-617) therapy profile (Image source: Novartis official website) This approval is based on the positive results of 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
.
"The approval of Pluvicto is an important clinical advance for patients with mCRPC that can significantly improve survival in these patients with limited treatment options
,
" said Dr.
Oliver Sartor of Tulane Cancer Center.
A major step forward in the development of precision medicine
.
"Reference: [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:// 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:// Disclaimer: Focused by WuXi AppTec Content Team Introduce the progress of global biomedical health research
.
This article is only for the purpose of information exchange.
The opinions in this article do not represent the position of WuXi AppTec, nor do they support or oppose the opinions in the article
.
This article is not a treatment plan recommendation
.
If you need treatment plan guidance , please go to a regular hospital for treatment
.
S.
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)-positive metastatic castration-resistant prostate cancer (mCRPC) patients
.
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
.
▲Pluvicto (177Lu-PSMA-617) therapy profile (Image source: Novartis official website) This approval is based on the positive results of 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
.
"The approval of Pluvicto is an important clinical advance for patients with mCRPC that can significantly improve survival in these patients with limited treatment options
,
" said Dr.
Oliver Sartor of Tulane Cancer Center.
A major step forward in the development of precision medicine
.
"Reference: [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:// 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:// Disclaimer: Focused by WuXi AppTec Content Team Introduce the progress of global biomedical health research
.
This article is only for the purpose of information exchange.
The opinions in this article do not represent the position of WuXi AppTec, nor do they support or oppose the opinions in the article
.
This article is not a treatment plan recommendation
.
If you need treatment plan guidance , please go to a regular hospital for treatment
.
