Novartis PLUVICTO™ for Prostate Cancer Becomes the First Targeted Radioligand Therapy

• Pluvicto is a targeted radioligand therapy for progressive PSMA-positive metastatic prostate cancer.
• The FDA approval of Pluvicto was based on two pivotal Phase III studies (VISION trial).
• A radioactive diagnostic agent, Locametz (gallium Ga 68 gozetotide), for PET of certain prostate cancer also received approval on the same day.

On March 23, 2022, a lutetium Lu 177 vipivotide tetraxetan namely PLUVICTO by a Novartis company (Advanced Accelerator Applications USA, Inc.) received FDA approval for the treatment of adult patients diagnosed with mCRPC- metastatic castration-resistant prostate cancer. Mainly, it is approved to treat tumors that are prostate-specific membrane antigen (PSMA)-positive in patients:

• who have been treated earlier with taxane-based chemotherapy and androgen receptor (AR) pathway inhibition; and
• whose tumor can otherwise not be treated using surgical procedures.

Another approval was granted by the US Food and Drug Administration on the same day. It is a radioactive diagnostic agent, Locametz (gallium Ga 68 gozetotide), for positron emission tomography (PET). It’s utilized to diagnose PSMA-positive lesions. With the approval, it becomes the first PET radioactive diagnostic agent to aid patient selection in the use of Pluvicto and other radioligand therapeutic agents.

Experts define PSMA-positive mCRPC as the detection of one or more tumor lesions having gallium Ga 68 gozetotide uptake bigger than a normal liver.

Pluvicto plus best standard of care (BSoC)or BSoC alone in 551 and 280 men respectively with progressive, PSMA-positive mCRPC was examined in the VISION Trial (NCT03511664), a randomized (2:1), multicenter, open-label study. All of the patients previously had bilateral orchiectomy or had received a GnRH analog. At least one AR pathway inhibitor, as well as one or two prior taxane-based chemotherapy regimens, were necessary. Pluvicto 7.4 GBq (200 mCi) was given every 6 weeks for a total of 6 doses plus BSoC or BSoC alone.

Overall survival (OS) and radiographic progression-free survival (RFS) were both significant improvements in the experiment (rPFS). For the comparison of Pluvicto plus BSoC against BSoC, the hazard ratio (HR) for OS was 0.62. The Pluvicto plus BSoC arm had a median OS of 15.3 months whereas the BSoC arm had a median OS of 11.3 months. Due to a high degree of filtering from early dropout in the control arm, interpretation of the magnitude of the rPFS effect was constrained.

The most common side effects of Pluvicto may include loss of appetite, anemia, nausea, dry mouth, fatigue, and constipation. Whereas, the notable laboratory abnormalities include decreased: hemoglobin, calcium, platelets, lymphocytes, and leukocytes.

The recommended dosage for Pluvicto is 7.4 GBq (200 mCi) to be administered intravenously (into a vein) every 6 weeks until unacceptable toxicity or disease progression.

View full prescribing information for Pluvicto.