Novartis Submits NDA in China for Pluvicto, a PSMA-Targeted Radioligand Therapy for Metastatic Castration-Resistant Prostate Cancer

Today (November 13), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) revealed that NovartisLutetium [¹⁷⁷Lu] Teseviptide InjectionTheNew Drug Marketing Application Accepted.Public information shows that this was developed by Novartis.PSMA-Targeted Radioligand Therapy Pluvicto（Former Name¹⁷⁷Lu-PSMA-617), which was previously approved by the U.S. FDA in March 2022 for the treatment of prostate cancer patients.In China, the product was granted priority review by the CDE in September this year.IndicationsAdult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have received androgen receptor pathway inhibitors and taxane-based chemotherapy.。

Screenshot source:CDE Official Website

At the same time, Novartis reported the radiopharmaceutical Gallium[⁶⁸Ga] The marketing application for the Gozetide Injection Preparation Kit has also been accepted and included in the priority review. This product is⁶⁸GaAfter radiolabelingCan be used as a radioactive diagnostic reagent.SuitableFor identifying PSMA-positive lesions in adult patients with prostate cancer through positron emission tomography (PET)。

RadiopharmaceuticalsWith the unique feature of "integration of diagnosis and treatment," it canUsing the same tumor marker as the target,Using radioligand imaging (RLI) technology targeting this site to search for and locate tumor lesions, and then delivering precise strikes to cancer cells with radioligand therapy (RLT) drugs targeting this site,HasPrecision, efficiency, and fewer side effects, among other advantages, have been highly regarded in the industry in recent years.

Pluvicto is a drug that combines a small molecule compound targeting PSMA with a radioactive isotope (¹⁷⁷Lu）Connected Radioligand Therapy.It can bind to prostate cancer cells expressing PSMA, while¹⁷⁷LuCapable of emitting beta rays, which precisely target and destroy tumors. Since the radiation released by Pluvicto only acts over a very short distance, it limits damage to surrounding healthy cells.

March 2022,Novartis announces FDA approval of the company'sPluvictoListed, for the treatment of PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) patients. They have already received chemotherapy based on taxanes and androgen receptor signaling pathway inhibitors. The press release noted that Pluvicto isThe first FDA-approved targeted radioligand therapy for the treatment of this type of mCRPC patients.AndAccording to the previously published inNature Reviews Clinical OncologyAs introduced in a review, this approval marks an important advancement in the field of radiopharmaceuticals, meaningRadioactive drugs begin to be used for treating more common malignant tumors like prostate cancer.。

FDAThis approval is based on the positive results of the pivotal Phase 3 clinical trial, the VISION study.Compared with standard treatment,Adding Pluvicto reduced the risk of death by 38% in patients.Pluvicto significantly reduces the risk of radiological disease progression or death in patients.Moreover,In patients with evaluable disease at baseline, the overall response rate was 30% in the Pluvicto group and 2% in the standard-of-care control group.

At the 2023 European Society for Medical Oncology (ESMO) Congress, Novartis also announced that the Phase 3 PSMAfore clinical trial of Pluvicto met its primary endpoint of radiographic progression-free survival (rPFS). Compared to switching to another androgen receptor pathway inhibitor (ARPI),PluvictoPatients TreatedReduced the risk of radiological progression by 59%. After extending the data cutoff date to a median follow-up time of 8.6 months, the updated rPFS results analysis confirmed the product's sustained clinical benefit compared to switching to another ARPI.The product extendsrPFSMore than twice as long (median time: 12.0 months vs 5.6 months)。

The submission of this radiopharmaceutical therapy for marketing approval in China and its inclusion in the priority review process indicates that the product is expected to reach patients more quickly.

According to the press release issued by Novartis during the recent China International Import Expo,As part of its goal to enter the early stages of the disease, the company has two Phase 3 studies evaluatingPluvictoInEarlier Treatment for PSMA-Positive Prostate CancerRole in China: PSMAddition Study is OngoingMetastatic Hormone-Sensitive PhaseConduct research, PSMA-DC study is being prepared forOligometastatic Stage。

Currently,Radioligand Therapy (RLT) has become one of the five major technology platforms that Novartis focuses on, together with chemotherapy, biologic therapy, gene and cell therapy, and xRNA therapy.Entering 2024, Novartis is also continuing to strengthen its presence in the RLT field, completing the acquisition of Mariana Oncology and its radiopharmaceutical pipeline for $1.75 billion.Acquisition, and with$2.99 billionCollaborate with PeptiDream in peptide discoveryCooperation ExpansionIn China, Novartis has launched several clinical studies on RLT therapy, covering both later-line and front-line prostate cancer treatments as well as other early pipeline products.