The FDA granted priority review to 177Lu-PSMA-617 in pretreated metastatic castration-resistant prostate cancer based on positive survival data from the phase 3 VISION study.
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.