Novartis AG Sponsored ADR pharmaceutical company (NVS.US) plans to include its innovative radiotherapy Pluvicto in China's priority review process for the treatment of prostate cancer.

The China National Medical Products Administration's Center for Drug Evaluation (CDE) recently announced on its official website that Novartis AG Sponsored ADR's pharmaceuticals, lutetium [177Lu] Pluvicto injection and gallium [68GGa] gozetide injection preparation for radiopharmaceuticals, are expected to undergo priority review. The former is used for treating metastatic castration-resistant prostate cancer (mCRPC) that is positive for prostate-specific membrane antigen (PSMA) and has received previous treatment with androgen receptor pathway inhibitors and taxane chemotherapy. The gallium [68GGa] gozetide injection preparation for radiopharmaceuticals, after being labeled with gallium-68 radioactivity, can be used as a radiopharmaceutical diagnostic agent for identifying PSMA-positive lesions in adult patients with prostate cancer through positron emission tomography (PET). Public information indicates that these are targeted radiopharmaceutical ligand therapies developed by Novartis AG Sponsored ADR, named Pluvicto (lutetium 177Lu vipivotide tetraxetan, formerly known as 177Lu-PSMA-617), which was approved by the US FDA in March 2022 for treating the aforementioned prostate cancer patients. Radiopharmaceuticals can develop diagnostic and therapeutic products targeting specific targets using the same ligand, providing a unique advantage of "diagnosis and treatment integration," making them highly favored by the industry in recent years. According to a review published in Nature Reviews Clinical Oncology, the approval of Novartis AG Sponsored ADR's Pluvicto, a targeted PSMA radiopharmaceutical, represents an important advancement in the field, indicating the use of radiopharmaceuticals in treating more common malignancies like prostate cancer. Pluvicto is a radiopharmaceutical ligand therapy that combines a small molecule targeting PSMA with a 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, leading to cell death. Since the radiation released by Pluvicto only acts within a short distance, it limits the damage to surrounding healthy cells. It is worth noting that Pluvicto has also been selected as a candidate for the Best Pharmaceutical Award at the 2024 Prix Galien USA Awards just announced. In March 2022, Novartis AG Sponsored ADR announced that FDA had approved its Pluvicto for the treatment of mCRPC patients positive for PSMA who have previously received taxane chemotherapy and androgen receptor signal pathway inhibitors. The press release stated that Pluvicto is the first targeted radiopharmaceutical therapy approved by FDA for treating such mCRPC patients. This approval was based on positive results from a pivotal Phase 3 clinical trial, the VISION study. The trial results showed that adding Pluvicto reduced the risk of death by 38% compared to standard treatment, and Pluvicto significantly reduced the risk of radiographic disease progression or death in patients. Additionally, in patients with assessable disease at baseline, the overall response rate in the Pluvicto group was 30%, compared to 2% in the standard treatment control group.