Novartis' Radioligand Therapy Pluvicto Receives Dual Indication Approval in China for PSMA-Positive mCRPC

On November 5, Novartis announcedLutetium [177Lu] Texiveptide Dual IndicationsApproved for marketing,Respectively used for treating patients who have previously received androgen receptor pathway inhibitors（ARPI）Prostate-Specific Membrane Antigen After Disease Progression and Suitable for Delayed Chemotherapy（PSMA）Positive Metastatic Castration-Resistant Prostate Cancer（mCRPC）Adult patients and PSMA-positive mCRPC adult patients with disease progression after prior treatment with ARPI and taxane chemotherapy.

Screenshot source: Novartis Official WeChat

Lutetium [177Lu] Texiveptide（177Lu-PSMA-617）It 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 will irradiate and kill the tumor cells.

Overseas, Pluvicto was successively approved by the U.S. FDA and the European EMA in 2022.Used for treating patients who have receivedAndrogen Receptor Pathway Inhibitors（ARPI）PSMA-Positive mCRPC Treated with Taxane Chemotherapy, that isThird-line TreatmentIn March 2025, the FDA approved the expanded indications for this drug again,Used in oneSeedAfter ARPI, Not PassedmCRPC patients receiving chemotherapy, i.e.Second-line Treatment。

Pluvicto is the first FDA-approvedTargetingCastration-Resistant Prostate CancerPatient's Targeted Radioligand Therapy, whose approval was based on the keyPhase III ClinicalPositive Results from the VISION Clinical Trial. The trial aimed to evaluate Pluvicto in combination with standard treatment.（SoC）Efficacy in mCRPC patients who have previously received at least one androgen receptor inhibitor and one to two taxane regimens, with positive PSMA expression.

The results showed that: compared with SoC,Pluvicto+SoC significantly extended radiographic progression-free survival (rPFS, 8.7 vs 3.4 months) and overall survival (OS, 15.3 vs 11.3 months).Moreover, compared with SoC, Pluvicto+SoC can reduce the risk of death for patients, as well as the risk of radiological disease progression or death.

FDA Approval of Pluvicto's 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 analysisThe median imaging-based progression-free survival in the Pluvicto group was more than doubled.(11.6 months vs. 5.6 months)。

Additional results from the PSMAfore study show that Pluvicto demonstrated a consistent and improved 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.

Insight database shows that the second year after Pluvicto was launched（2023 Year）Sales reached$9.8 billion，with a year-on-year growth rate as high as 261.62%.Novartis 2024 Financial Report Shows Global Sales of the DrugSales reachedUSD 1.392 billion。

Screenshot source: Insight database

Radiopharmaceuticals, represented by radioligand therapy, are a key area of significant investment for Novartis.In addition to Pluvicto, Novartis also has another radiopharmaceutical, Lutathera, which has been approved for marketing and is used for somatostatin receptor-positive conditions.（SSTR+）Adult patients with gastrointestinal pancreatic neuroendocrine tumors, and later approved for pediatric patients aged 12 years and above.Lutathera Sales Reached $605 Million in 2023 and $724 Million in 2024。

According to Novartis' disclosure in 2025Third Quarter Earnings Report，Total Revenue of Pluvicto and Lutathera$2.002 billion。

With Pluvicto and Lutathera,Novartis occupies a leadership position in the therapeutic nuclear medicine field.Novartis' layout in the nuclear medicine sector has mostly been achieved through acquisitions or collaborations. As early as 2017, Novartis acquired Lutathera by purchasing Advanced Accelerator Applications and established a nuclear medicine technology platform, with the transaction amounting to approximately $3.9 billion. In 2018, Novartis further spent $2.1 billion to acquire Endocyte, expanding its nuclear medicine pipeline.

In recent years, Novartis has reached several deals in the radiopharmaceuticals sector. Overall, the total amount of transactions Novartis has completed in the radiopharmaceutical field has exceeded tens of billions of US dollars, and it has also started to lay out investments in cyclic peptide radioconjugate drugs.

Screenshot source: Insight database

In addition, other MNCs are also actively entering the radiopharmaceuticals sector and have reached multiple deals.(More transactions can be found in the Insight database「Pharmaceutical Transactions"Module Query）：

• In May 2023, Bayer collaborated with Bicycle to jointly develop bicyclic peptide radionuclide conjugates;
• In September 2023, Roche and PeptiDream reached a collaboration to jointly discover and develop novel macrocyclic peptide-radiopharmaceutical conjugates.
• In October 2023, Eli Lilly invested $1.4 billion to acquire POINT Biopharma, a radiopharmaceutical company;
• In December 2023, BMS spent $4.1 billion to acquire radiopharmaceutical company RayzeBio;
• In March 2024, AstraZeneca spent $2.4 billion to acquire a company focused on developing the next generation of radiopharmaceuticals.（RDC）Biopharmaceutical company Fusion Pharmaceuticals;
• In September 2024, Sanofi entered into an exclusive licensing agreement with RadioMedix and Orano Med, totaling approximately 320 million euros, to jointly develop radioligand therapy based on the isotope 212Pb.（RLT）For cancer treatment.

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