Lu177 PSMA 617 FDA Approval and Access
On Wednesday, March 23 of this past week, the FDA finally approved Lutetium 177 PSMA 617 for treatment of PSMA (prostate specific membrane antigen) sensitive metastatic castrate resistant prostate cancer (mCRPC). The ligand, lutetium Lu 177 vipivotide tetraxetan, has a commercial name of Pluvicto, and is made by Advanced Accelerator Applications, a subsidiary of Novartis. Novartis is an AnCan sponsor – they have not asked us to make this post.
Pluvicto delivers the radionuclide agent lutetium to cells expressing PSMA . According to Dr. Jeremie Calais at UCLA, “The PSMA-targeted radioactive agent preferentially atttaches to cancerous cells, not the normal tissues”.
You can read the Novartis press release here, and an independent review from Prostate Cancer Foundation here.
The approval left a lot of open questions, several of which AnCan was able to answer when we spoke with AAA on Friday. There are a couple of quirks in the approval and availability.
- Use of Pluvicto (Lu177 PSMA 617) is post-chemotherapy
- Use requires a Ga68 PSMA 11 scan – not Pylarify. AAA received a companion approval for Locametz, a kit that makes that scan widely available. It is not clear if a previous Pylarify scan will be grandfathered
- There is no Medicare pricing agreement as yet
- University of Chicago
- Tulane
- Mount Sinai, NYC
- UCLA