Today (September 24), CDE plans to include Novartis' Lutetium [177Lu] Texivirpitide Injection and Radioactive Drug Gallium [68Ga] Gozertide Injection Preparation Kit in the priority review.
According to the CDE official website, both drugs are based on the "Opinions of the National Medical Products Administration on Reforming and Improving the Management System for the Review and Approval of Radioactive Drugs" (National Medical Products Administration Drug Note [2023] No. 20) and the "Medium- and Long-Term Development Plan for Medical Isotopes (2021-2035)". After review, they comply with the "Drug Registration Management Measures" and the "Announcement of the National Medical Products Administration on the Release of the "Breakthrough Therapeutic Drug Review Work Procedures (Trial)" and other three documents (No. 82 of 2020). The requirements are agreed to be included in the priority review and approval procedure according to the priority review scope "(VI) Other circumstances prescribed by the National Medical Products Administration for priority review and approval".

Lutetium [177Lu] tetraxevotide injection is intended for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have received androgen receptor pathway inhibition and taxane chemotherapy. According to public information, lutetium (177Lu) vipivotide tetraxetan injection (177Lu-PSMA-617) is a radioligand therapy targeting PSMA, which couples the small molecule targeted drug PSMA-617 to the radioactive isotope 177Lu. 177Lu-PSMA-617 locates the prostate cancer cell cluster through the PSMA molecule, and delivers the radioactive source to the prostate cancer cells without affecting the surrounding cells for precise radiation. In March 2022, the drug was approved for marketing by the US FDA.

The radioactive drug gallium [68Ga] gozetide injection preparation kit can be used as a radioactive diagnostic reagent after being radiolabeled with gallium-68, and is suitable for identifying prostate-specific membrane antigen (PSMA)-positive lesions in adult patients with prostate cancer through positron emission tomography (PET).

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