The good news for our Canadian patients is that Health Canada has approved Pluvicto (lutetium (177Lu) vipivotide tetraxetan injection) for the treatment of men with prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer (mCRPC) who have received at least one androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy.
Pluvicto is a precision cancer treatment that combines a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle). This means that the radioisotope treatment (a radioactive particle) is delivered directly to the cancer cells.
Now, let's unpack who could qualify to receive this treatment.
1- This particular approval only affects men living and being treated in Canada; other countries have already approved Pluvicto.
2- Men must have confirmed metastatic castrate-resistant prostate cancer (mCRPC). This means that the prostate cancer must have left the prostate gland and spread to a different site other than the prostate gland. In addition, the prostate cancer must have stopped responding to first-line hormone therapy treatments (ADT) like Lupron, Eligard, Trelstar, or Zoladex.
Treatment nonresponse is measured by a rising prostate-specific antigen (PSA blood test) despite confirming that these medications have dropped the testosterone blood levels to a castrate level.
3- Men must also have had and failed (as indicated by a rising PSA blood test) at least one of the second-line or androgen receptor pathway inhibitor (ARPI) medications like Erleada (apalutamide), Nubequa (darolutamide), Xtandi (enzalutamide) or Zytiga (abiraterone).
4- Men must also have chemotherapy with a taxane-based drug like Taxotere (docetaxel) or Jevtana (cabazitaxel).
5- The prostate cancer must be confirmed to be PSMA positive, or the tumor must express prostate-specific membrane antigen (PSMA) on the cancer cell's surface. Only about 80% of prostate cancer is PSMA positive. A positive PSMA scan confirms the presence of PSMA.
To qualify, men must meet all of the above criteria.
Pluvicto is administered into the bloodstream by a specially trained doctor who handles radioactive drugs. Once the drug is administered, the Pluvicto targets (finds) the PSMA being expressed on the prostate cancer cell surfaces, directly delivering the treatment radioisotope to the cancer cell. The radioisotope disrupts the cancer cell's ability to duplicate itself and triggers cell death.
The Health Canada approval of Pluvicto is based on the pivotal Phase III VISION trial results. The trial randomized patients with PSMA-positive mCRPC who received 177Lu-PSMA-617 in addition to best supportive/best standard of care (BSC/BSoC) versus patients treated with BSC/BSoC alone.
The full product monograph for Pluvicto can be found at https://www.adacap.com/our-products/.
