Novartis gets positive EMA panel opinion for prostate cancer drug Pluvicto
Pluvicto is a radioligand therapy combining a targeting compound (ligand, in this case directed to PSMA) with a therapeutic radioisotope;
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Basel: Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization for Pluvicto (INN: lutetium (177Lu) vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617), a radioligand therapy, in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition, for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane-based chemotherapy.
"People at this advanced stage of the disease have already received many different treatments and have few alternatives left," said Prof. Karim Fizazi, MD, Ph.D., VISION trial investigator and
Head of Medical Oncology at Gustave Roussy, the first European cancer center based in Villejuif, France. "If approved in Europe, Pluvicto would represent a new type of precision medicine targeting a biomarker broadly expressed in prostate cancer patients and provide a therapeutic option with demonstrated potential to improve outcomes. As a clinician, this gives me hope for patients facing a very difficult situation."
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