The radiopharmaceutical drug, called Pluvicto, received marketing authorization from the Medicines & Healthcare products Regulatory Agency (MHRA) for treating adult patients with PSMA-positive metastatic castration-resistant prostate cancer who have previously received other anticancer therapies, such as androgen receptor therapy or taxane-based chemotherapy.
In addition, the MHRA approved Locametz (gozetotide), the company's kit for the preparation of the radiotracer gallium-68 (Ga-68) PSMA-11, which is used in PET imaging to identify metastatic prostate cancer; it is the first diagnostic PSMA imaging tracer to receive this status from the MHRA, Novartis noted.
Radioligand therapy (RLT) is an emerging treatment approach that may offer an alternative treatment option for some cancer patients. It combines a targeting compound (ligand) with a therapeutic radioisotope. RLT is administered via the bloodstream and delivers targeted radiation to cancer cells in the body, with the goal of limiting damage to surrounding tissue.
"Radioligand therapy is an upcoming pillar of cancer care, and we are delighted that the U.K. is the second region in the world to license this pioneering treatment to advanced prostate cancer patients," said Alessandra Dorigo, General Manager UK & Ireland, Baltics and Nordics of Advanced Accelerator Applications, a Novartis company.
Novartis is working with the National Health Service to ensure system readiness so that eligible patients are able to access this medicine when available, he added.
Pluvicto was approved by the U.S. Food and Drug Administration in March.
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