UK Grants Marketing Authorization for Novartis’ Radioligand Therapy for Advanced Prostate Cancer

Novartis announced on Aug. 11, 2022, that the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Pluvicto (lutetium (177Lu) vipivotide tetraxetan) for the treatment prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in adult patients who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.

An emerging therapy approach, radioligand therapy may offer an alternative treatment option for some cancer patients, by combining a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle). It is administered via the bloodstream and delivers targeted radiation to cancer cells in the body while aiming to limit damage to surrounding tissue.

“Far too many people are still dying each year from prostate cancer. Tragically, those diagnosed with metastatic prostate cancer will only have about a 1 in 2 chance of surviving 5 years,” said Steve Allen, acting chair of Tackle Prostate Cancer, in a company press release. “Today’s announcement of marketing authorization for lutetium treatment is another positive milestone for eligible patients and their families. There continues to be a real and pressing need for better treatments for people with advanced prostate cancer. This new approach is very welcome.”