Prostate Cancer Drug Nabs Breakthrough Therapy Designation

The FDA has granted Breakthrough Therapy designation (BTD) to Novartis’s targeted investigational radiation therapy, 177Lu-PSMA-617 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

The designation is based on positive data from the pivotal phase 3 VISION study, which demonstrated that the targeted radioligand therapy plus standard of care (SOC) significantly improved overall survival and radiographic progression-free survival for men with progressive PSMA-positive mCRPC2 compared with SOC alone.

“The study demonstrated that 177Lu-PSMA-617 improves disease progression and prolongs survival, which are key measures of clinical benefit in the mCRPC population. I am grateful to be a part of this study that may lead to additional therapeutic options for these patients,” Michael J. Morris, M.D., who chaired the study’s scientific committee and is the prostate cancer section head, Genitourinary Oncology Service, Division of Solid Tumor Oncology at Memorial Sloan Kettering Cancer Center, said in a statement.

The investigational therapy attaches a radioactive isotope, lutetium-177, with a half-life of less than seven days, to a small molecule drug, PSMA-617, which binds to an antigen expressed in large amounts by prostate cancer cells. Once bound, it disrupts the cancer cell’s ability to replicate or triggers cell death. This therapeutic approach enables targeted delivery of radiation to the tumor, while limiting damage to the surrounding normal tissue.

Two additional studies with 177Lu-PSMA-617 therapy in earlier lines of treatment for metastatic prostate cancer are ongoing, investigating potential clinical utility in the mCRPC pre-taxane setting (PSMAfore) and in the metastatic hormone-sensitive setting (PSMAddition).

The therapy is being developed by Advanced Accelerator Applications, a Novartis company.