USA – The U.S. Food and Drug Administration has approved Novartis’ therapy for the treatment of patients with a type of advanced prostate cancer that has spread to other parts of the body.

Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a targeted radioligand therapy for adult patients who have previously received anticancer treatment.

The company said the decision makes Pluvicto, which is expected to be available within weeks, the first FDA-approved treatment for eligible patients that combines a targeting compound with a therapeutic radioisotope.

The therapy was purchased as part of the company’s US$2.1 billion purchase of cancer drugmaker Endocyte in 2018.

According to Novartis, Pluvicto is a precision treatment that combines a targeting compound, or ligand, with a cancer-killing radioactive particle.

Pluvicto has been submitted for marketing authorization to the European Medicines Agency and other health authorities, according to the company.

According to Novartis, two late-stage studies evaluating Pluvicto in earlier lines of treatment for metastatic prostate cancer are currently underway.

The Oncology Approval was based on the findings of the Phase III VISION trial, which compared the addition of Pluvicto to standard care in 831 prostate-specific membrane antigen (PSMA) –positive metastatic castration-resistant prostate cancer (mCRPC) patients whose disease had progressed despite prior taxane and androgen receptor-directed therapy.

A 38% increase in survival

In comparison to standard care alone, patients who also received Pluvicto had a 38% lower risk of death, as well as a statistically significant lower risk of radiographic disease progression or death (rPFS).

The magnitude of the rPFS benefit, according to Novartis, “was limited due to a high degree of censoring from early drop out in the control arm.”

Furthermore, with the addition of Pluvicto, 30% of patients with evaluable disease at baseline achieved an overall response, compared to only 2% in the standard care alone arm.

The most common side effects of radioligand therapy were fatigue, dry mouth, nausea, and anemia, as well as decreased appetite and constipation.

Novartis said the FDA also approved Locametz, which is a kit for the preparation of gallium Ga 68 gozetotide injection.

After radiolabeling, the imaging agent may be used to identify PSMA-positive lesions in patients with mCRPC through a positron emission tomography (PET) scan.

The Swiss drugmaker acquired Pluvicto, previously known as 177Lu-PSMA-617, via its takeover of Endocyte in 2018. It has submitted filings for Pluvicto to the European Medicines Agency and other regulators, and says two pivotal Phase III studies are underway evaluating the treatment in earlier lines of therapy for metastatic prostate cancer.

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