Radioligand Therapy for PSMA-Positive mCRPC Gets Health Canada Approval

Advanced Accelerator Applications Canada Inc., a Novartis company, announced Health Canada approval for PLUVICTO (lutetium (177Lu) vipivotide tetraxetan injection) for the treatment of adult patients 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 the first targeted radioligand therapy (RLT) approved in Canada for eligible patients with mCRPC, a precision cancer treatment that combines a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle). Once it is administered into the bloodstream, PLUVICTO binds to target PSMA-positive cancer cells to deliver radiation treatment directly to those cells and nearby cells, disrupting their ability to replicate and/or triggering cell death.

"The approval of PLUVICTO is a major step forward in precision medicine for patients whose cancer has progressed to mCRPC and who have limited treatment options. They now have the chance to receive a therapy that selectively seeks out cells that express PSMA and delivers targeted radiation," said Dr Urban Emmenegger, Medical Oncologist at the Odette Cancer Centre of Sunnybrook Health Sciences Centre in Toronto. "This pioneering approach is an advancement in the metastatic prostate cancer setting that gives new hope to these patients who have exhausted multiple avenues of treatment."

In metastatic prostate cancer, if cells have an abundance of the PSMA biomarker, it means the cancer is PSMA positive.

"This approval has the potential to alter the treatment paradigm for patients with metastatic prostate cancer. We are proud to be at the forefront of innovative precision medicine," said Lyndal Walker, President & General Manager, Advanced Accelerator Applications Canada Inc. "The arrival of PLUVICTO demonstrates our strong commitment to making a meaningful difference for the lives of patients through ongoing research and advancements in nuclear medicine and targeted radioligand therapies."

The Health Canada approval of PLUVICTO is based on the results of the pivotal Phase III VISION trial which 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.