Novartis Receives FDA Priority Review for Radioligand Therapy 177Lu-PSMA-617 in Metastatic Castration-Resistant Prostate Cancer

Today, Novartis announced that the U.S. FDA has accepted the company's New Drug Application (NDA) for the targeted radioligand therapy 177Lu-PSMA-617 and granted it Priority Review designation for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy and androgen receptor pathway inhibitors.

In recent years, radiopharmaceuticals have emerged as an important direction in the field of precision oncology. Novartis’s 177Lu-PSMA-617 conjugates a small-molecule compound that binds to prostate-specific membrane antigen (PSMA) with a radioactive isotope. It binds to PSMA-expressing prostate cancer cells, and the radiation energy released by the radioisotope damages the tumor cells, triggering cell death. Because the radiation emitted by 177Lu-PSMA-617 acts only over a very short range, it limits damage to surrounding healthy cells. This therapy previously received Breakthrough Therapy designation from the FDA.

▲Introduction to 177Lu-PSMA-617 Therapy (Image source: Novartis official website)

Priority review designation is based on positive results from a pivotal Phase 3 clinical trial, which demonstrated that, compared with standard of care, 177Lu-PSMA-617 in combination with standard of care significantly improved overall survival (OS) and radiographic progression-free survival (rPFS) in PSMA-positive patients.

According to data presented at the 2021 ASCO Annual Meeting, the median overall survival in patients was extended by 4 months, with a 38% reduction in the risk of death (HR=0.62, 95% CI: 0.52–0.74) and a 60% reduction in the risk of radiographic disease progression or death (HR=0.40, 99.2% CI: 0.29–0.57). In terms of safety, the incidence of treatment-related adverse events was higher in the 177Lu-PSMA-617 group (85.3%) than in the control group (28.8%).

The U.S. FDA is expected to issue a response in the first half of 2022. Novartis is currently evaluating the efficacy of 177Lu-PSMA-617 in patients with earlier-stage prostate cancer.

References:

[1] FDA grants Priority Review for investigational targeted radioligand therapy 177Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer (mCRPC). Retrieved September 28, 2021, from https://www.novartis.com/news/fda-grants-priority-review-investigational-targeted-radioligand-therapy-177lu-psma-617-patients-metastatic-castration-resistant-prostate-cancer-mcrpc

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