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Today, Novartis announced that the US FDA has accepted the company's new drug application (NDA) for the targeted radioligand therapy 177Lu-PSMA-617 and granted it priority review status for the treatment of metastatic castration-resistant prostate Cancer (mCRPC) patients
In recent years, radiopharmaceuticals have become an important direction in the field of tumor precision treatment
▲Introduction to 177Lu-PSMA-617 therapy (picture source: Novartis official website)
The priority review qualification is based on the positive results of the pivotal Phase 3 clinical trial.
According to the data released at the ASCO annual meeting in 2021, the median overall survival of the patient was extended by 4 months, the risk of death was reduced by 38% (HR=0.
The US FDA is expected to respond in the first half of 2022.
Reference materials:
[1] FDA grants Priority Review for investigational targeted radioligand therapy 177Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer (mCRPC).
