Novartis announced today that the US Food and Drug Administration (FDA) approved Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) for the treatment of adult patients with a certain type of advanced cancer called prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) that has spread to other parts of the body (metastatic)1. These patients have already been treated with other anti-cancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy).
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“The approval of Pluvicto is an important clinical advancement for people with progressing mCRPC, as it can significantly improve survival rates for those who have limited treatment options,” said Oliver Sartor, MD, Medical Director at Tulane Cancer Center. “Pluvicto is a step forward in the evolution of precision medicine for prostate cancer.”
Pluvicto is the first FDA-approved targeted radioligand therapy (RLT) for eligible patients with mCRPC that combines a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle)1. Pluvicto is expected to be available to physicians and patients within weeks.
The FDA has also approved Locametz® (kit for the preparation of gallium Ga 68 gozetotide injection)2. After radiolabeling, this imaging agent may be used to identify PSMA-positive lesions in adult patients with mCRPC through a positron emission tomography (PET) scan2. Gallium-68 labeled Locametz can identify tumor lesions expressing the PSMA biomarker and locate where in the body tumors may have spread (eg, in soft tissue, lymph nodes, or bone), identifying patients eligible for targeted treatment with Pluvicto1,2. PSMA is highly expressed in more than 80 percent of patients with prostate cancer, making it an important phenotypic biomarker for assessing the progression of metastatic prostate cancer10. Locametz is expected to be available to physicians and patients within weeks.
“With our unique strategy to tackle cancer by leveraging four therapeutic platforms, I am thrilled that with Pluvicto, we are bringing the targeted RLT platform to bear for treating eligible patients with mCRPC,” said Susanne Schaffert, PhD, President, Novartis Oncology. “Today’s approval builds upon our history in prostate cancer, a devastating disease where we believe our innovation can make a meaningful difference to patients.”