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FDA approves radioligand therapy Pluvicto for prostate cancer

 Last Update: 2022-04-23
 Source: Internet
 Author: User

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Despite recent advances in the treatment of prostate cancer, metastatic castration-resistant prostate cancer remains lethal
.

Prostate-specific membrane antigen (PSMA) is highly expressed in metastatic castration-resistant prostate cancer

Novartis today announced that the FDA has approved its Pluvicto (Lutetium-177-PSMA-617) for adults with previously treated PSMA-positive metastatic castration-resistant prostate cancer (mCRPC)
.

The company said the decision puts Pluvicto, a treatment that combines a targeted compound with a therapeutic radioisotope, on track within weeks

FDA

Approval was based on results from the Phase III VISION trial, which was designed to evaluate the efficacy and safety of Pluvicto in combination with standard therapy in patients with PSMA-positive mCRPC who had disease progression after prior treatment with paclitaxel and novel hormonal therapy
.

From June 2018 to October 2019, a total of 831 subjects were randomized
.

The median follow-up time was 20.

Compared with standard of care, Pluvicto combined with standard of care significantly prolonged median PFS (8.

Overall, the addition of Pluvicto to standard of care in patients with advanced PSMA-positive metastatic castration-resistant prostate cancer prolonged imaging-based progression-free survival and overall survival

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FDA approves Novartis' targeted radioligand therapy Pluvicto for prostate cancer

04-29

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FDA approves radioligand therapy Pluvicto for prostate cancer

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FDA approves Novartis' targeted radioligand therapy Pluvicto for prostate cancer