Novartis Submits New Indication Application for Pluvicto in China Targeting Second-Line Treatment of PSMA-Positive mCRPC

On April 28, the CDE website showed that Novartis had submitted an application in China.Lutetium [177Lu] Texiveptide InjectionNew Indication Marketing Application(Application No.: JXHS2500054)Based on the progress of the drug's research, the indications for this application may be:Second-line Treatment for PSMA-positive Castration-resistant Prostate Cancer。

Pluvicto(Lutetium [177Lu]-Texiveptide)Is a radioligand therapy administered via intravenous injection（RLT）, composed of targeting ligands and therapeutic radionuclides(Lutetium-177)Combined. Once in the bloodstream, Pluvicto can specifically bind to prostate-specific membrane antigen (PSMA).（PSMA）Prostate cancer cells. After binding, the energy released by the radioactive isotope can destroy the target cells, inhibit their replication ability, and/or trigger tumor cell death.

Outside of China, Pluvicto was successively approved by the U.S. FDA and the European EMA in 2022 for use inPSMA-Positive Castration-Resistant Prostate Cancer Third-Line TreatmentIn March 2025, the FDA approved the expanded indications for this drug again,Used in an androgen receptor pathway inhibitor（ARPI）Post-treatment, chemotherapy-naïve mCRPC patients, i.e.Second-line Treatment。

In ChinaPluvicto submitted its first marketing application in September 2024.(Application No.:JXHS2400095），And has been included in the priority review, applicableFor treatmentPSMA PositiveMetastatic Castration-Resistant Prostate Cancer（mCRPC）Adult patients who have received androgen receptor pathway inhibitors and taxane chemotherapy, or third-line treatment.

Novartis is currently conducting a project in ChinaOpen-label, Multicenter, Randomized, Phase II Study（CTR20230581），PurposeIn notProgression after taxane treatmentIn mCRPCIn Chinese male patients(Second-line Treatment)，EvaluationThe effectiveness of Pluvicto compared to switching to another androgen receptor-targeted therapy in prolonging rPFS. The primary endpoint of the study was completed in December 2024.

FDA Approval of Pluvicto for Second-Line Indication Based on Phase III PSMAfore Clinical Trial Results, the study expands the patient population eligible for Pluvicto treatment by approximately three times.. The research results show that, compared with changing the ARPI regimen,Pluvicto Reduces Risk of Radiographic Progression or Death by 59% in PSMA-Positive mCRPC Patients（HR=0.41；95%CI：0.29-0.56；p＜0.0001）. In the updated exploratory analysis, The median imaging-based progression-free survival in the Pluvicto group more than doubled.(11.6 months vs. 5.6 months)。

Other results from the PSMAfore study showed that Pluvicto demonstrated a consistent and better safety profile.The most common adverse events of all grades were mainly grade 1-2, including dry mouth, fatigue, nausea, and constipation. Pluvicto does not affect the patient's ability to receive subsequent chemotherapy.

Pluvicto is a blockbuster product in Novartis' nuclear medicine field. The drug received its global first approval in 2022.In 2024, its sales achieved a 42% increase, breaking through the one-billion-dollar mark for the first time to reach 1.392 billion dollars., becoming another blockbuster under Novartis. With the expansion of new indications, Pluvicto is expected to accelerate its growth in the future.

Source: Insight Database