Novartis Announces FDA Approval of Pluvicto, First Targeted Radioligand Therapy for PSMA-Positive mCRPC

On March 23, Novartis announced that the U.S. FDA had approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, 177Lu-PSMA-617) for marketing. It is indicated for the treatment of adult patients with advanced prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) who have been treated with other anticancer therapies (androgen receptor pathway inhibitors and taxane chemotherapy).

Pluvicto is the first targeted radioligand therapy (RLT) approved by the FDA for the treatment of this type of mCRPC patient. This therapy combines a targeting compound (ligand) with a therapeutic radioisotope (radioparticle). On September 28 last year, its marketing application received priority review status from the FDA.

FDA also approved the auxiliary diagnostic contrast agent Locametz (gallium-68) for identifying PSMA-positive lesions.

More than 80% of prostate cancer patients highly express PSMA. 177Lu-PSMA-617 has a high affinity for PSMA, enabling it to deliver 177Lu to tumor cells. The β-particles released by 177Lu have a range of only 1 mm, minimizing damage to surrounding normal tissues.

The FDA approval was based on the results of the Phase III VISION trial. The trial demonstrated that, compared to standard of care (SOC), PSMA-positive mCRPC patients who had previously received androgen receptor (AR) pathway inhibitors and taxane-based chemotherapy showed improved overall survival with Pluvicto + SOC, with a 38% reduction in the risk of death and a significant statistical difference in the risk of radiographic disease progression or death (rPFS).

177Lu-PSMA-617 was initially developed by Endocyte. On October 18, 2018, Novartis reached an acquisition agreement with Endocyte to acquire all outstanding shares of Endocyte at a price of $24 per share, thereby acquiring this drug.