Tides Express | Novartis' Breakthrough Radiopharmaceutical Pluvicto Submitted for Market Approval in China!

November 2024Day 13，The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recently announced that Novartis' new drug, Lutetium [177Lu] Texiveptide Injection, has been submitted for review.The city's application has been accepted. The drug has been included in the priority review by the CDE and is intended for the treatment of metastatic castration-resistant prostate cancer with positive prostate-specific membrane antigen (PSMA).Patients with metastatic castration-resistant prostate cancer (mCRPC) who have received androgen receptor pathway inhibitors and taxane chemotherapy.This drug is the first targeted radioligand therapy approved by the FDA for patients with castration-resistant prostate cancer, and this is the first time it has been submitted for marketing in China.

Lutetium [177Lu] Texiveptide (177Lu-PSMA-617) is a PSMA-targeted radioligand therapy that connects PSMA-617 with the beta-emitting 177Lu. After binding to prostate cancer cells expressing PSMA, the radiation energy released by 177Lu irradiates and kills the tumor cells.

In March 2022, lutetium [177Lu] vipivotide tetraxetan was approved by the FDA for the treatment of PSMA-positive adult metastatic castration-resistant prostate cancer (mCRPC) in patients who have been treated with androgen receptor (AR) inhibitors and taxane chemotherapy, marketed under the brand name Pluvicto.

Pluvicto is the first FDA-approved targeted radioligand therapy for the treatment of this type of mCRPC patient, and its approval was based on the positive results of the pivotal Phase III clinical trial VISION. The trial aimed to evaluate the efficacy of Pluvicto in combination with standard of care (SoC) in mCRPC patients who had previously received at least one androgen receptor inhibitor and one to two taxane regimens and were PSMA-positive.

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Novartis is committed to reimagining medicine to improve people’s quality of life and extend human lifespan.We provide high-value medicines that can reduce the greatest disease burden on society through our technological leadership in R&D and innovative accessibility initiatives.In the process of exploring new drugs, we persistently innovate, and our R&D investment has always been at the forefront of the global industry.Novartis has approximately 106,000 employees from over 140 countries and regions worldwide, and nearly 800 million patients globally benefit from Novartis products.