Novartis' Innovative Radioligand Therapy Pluvicto and Diagnostic Agent LocaGall Kit Recommended for Priority Review in China for Prostate Cancer

According to the Zhitong Finance APP, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration has just announced that Novartis (NVS.US) Lutetium [177Lu] Texitopeptide Injection andKit for the Preparation of Radiopharmaceutical Gallium [68Ga] Gozetotide InjectionProposed for priority review, the former is applicable for the treatment of metastatic castration-resistant prostate cancer (mCRPC) that is positive for prostate-specific membrane antigen (PSMA) in adult patients who have received androgen receptor pathway inhibitors and taxane chemotherapy.Gallium [68Ga] Gozetotide Injection Preparation KitAfter being radiolabeled with gallium-68, it can be used as a radiodiagnostic agent, suitable for identifying PSMA-positive lesions in adult patients with prostate cancer through positron emission tomography (PET).

Public information shows that this is Pluvicto (lutetium 177Lu vipivotide tetraxetan, formerly known as 177Lu-PSMA-617), a PSMA-targeted radioligand therapy developed by Novartis. It was previously approved by the U.S. FDA in March 2022 for the treatment of the aforementioned prostate cancer patients.

Radiopharmaceuticals can leverage the same ligand to develop diagnostic and therapeutic products targeting specific sites, offering a unique "theranostic" advantage, and thus have been highly regarded in the industry in recent years. According to a review previously published in Nature Reviews Clinical Oncology, the approval of Pluvicto, a PSMA-targeted radiopharmaceutical developed by Novartis, marks a significant advancement in this field, indicating that radiopharmaceuticals are now being used to treat more common malignant tumors such as prostate cancer.

Pluvicto is a radioligand therapy that links a small molecule compound targeting PSMA with the radioactive isotope (177Lu). It can bind to prostate cancer cells expressing PSMA, and the radiation energy released by the radioactive isotope damages the tumor cells, triggering cell death. Since the radiation released by Pluvicto can only act over a very short distance, this limits the drug's damage to surrounding healthy cells.

Notably, Pluvicto has also been shortlisted for the recently announced 2024 Prix Galien USA Awards in the Best Pharmaceutical Agent category.

In March 2022, Novartis announced that the FDA had approved the company's Pluvicto for marketing, used to treat patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have already undergone taxane-based chemotherapy and androgen receptor signaling pathway inhibitor treatment. The press release noted that Pluvicto is the first FDA-approved targeted radioligand therapy for treating this type of mCRPC patient.

This FDA approval is based on the positive results of the pivotal phase 3 clinical trial, VISION study. The trial results showed that, compared with standard treatment, the addition of Pluvicto reduced the risk of death by 38%. Pluvicto also significantly reduced the risk of radiological disease progression or death. Moreover, in patients with evaluable disease at baseline, the overall response rate in the Pluvicto group was 30%, compared to 2% in the standard treatment control group.