FDA Grants Priority Review to 177Lu-PSMA-617 for Previously Treated Metastatic Castration-Resistant Prostate Cancer

The FDA granted priority review to a new drug application (NDA) for the investigational targeted radioligand therapy ¹⁷⁷Lu-PSMA-617 to treat patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received androgen-receptor pathway and taxane-based chemotherapy, according to a release from the company responsible for the NDA, Novartis.¹

The target Prescription Drug User Fee Act (PDUFA) date is the first half of 2022.

Priority review was granted based on positive data from the phase 3 VISION study (NCT03511664) examining ¹⁷⁷Lu-PSMA-617 plus protocol-permitted standard-of-care (SOC) therapy vs SOC alone for patients with progressive prostate-specific membrane antigen (PSMA)–positive mCRPC.²

A total of 831 patients in the VISION study were randomized 2:1 to either 7.4 GBq of ¹⁷⁷Lu-PSMA-617 every 6 weeks for 4 to 6 cycles plus protocol-permitted standard therapy or SOC alone.

Median imaging-based progression-free survival (PFS) was significantly longer among patients in the ¹⁷⁷Lu-PSMA-617 arm at 8.7 months compared with 3.4 months in patients in the SOC-alone arm (HR, 0.40; 99.2% CI, 0.29-0.57; P < .001).

A similar benefit was observed for overall survival (OS), with medians 15.3 months and 11.3 months for patients in the ¹⁷⁷Lu-PSMA-617 and SOC-alone arms, respectively (HR, 0.62; 95% CI, 0.52-0.74; P < .001).

Although the incidence of grade 3 or higher adverse effects was increased among patients in the ¹⁷⁷Lu-PSMA-617 arm, quality of life for these patients was not adversely impacted.

¹⁷⁷Lu-PSMA-617 was previously granted Breakthrough Therapy Designation by the FDA in June 2021 for the treatment of patients with mCRPC based on data from the same phase 3 VISION study.

There are 2 ongoing phase 3 studies examining ¹⁷⁷Lu-PSMA-617 in earlier lines of therapy for patients with mCRPC, PSMAfore (NCT04689828) and PSMAddition (NCT04720157). PSMAfore is examining ¹⁷⁷Lu-PSMA-617 versus androgen receptor–directed therapy for patients with progressive mCRPC who have not received taxane-based chemotherapy. PSMAddition is looking at ¹⁷⁷Lu-PSMA-617 plus SOC versus SOC alone for metastatic hormone-sensitive 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). News release. Novartis. September 28, 2021. Accessed October 4, 2021. https://tinyurl.com/2tjfrjvh
2. Sartor O, de Bono J, Chi KN, et al. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021;385(12):1091-1103. doi:10.1056/NEJMoa2107322