Novartis to file for Pluvicto label expansion

Novartis said it will file for a label expansion with the U.S. Food and Drug Administration (FDA) later this year to expand the use of its Pluvicto radiopharmaceutical drug to patients with earlier cases of prostate cancer.

Currently, Pluvictro (lutetium-177 [Lu-177] prostate-specific membrane antigen [PSMA]-617) is indicated in adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have previously received other anticancer therapies. The new filing follows additional data from the phase III PSMAfore study that demonstrates favorable overall survival (OS) data for patients treated earlier, according to the company.

Patients are required to undergo PSMA-PET scans to determine whether they are eligible for the treatment.

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