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Novartis to Seek Pluvicto Approval in Another Advanced PSMA-Positive Prostate Cancer Setting

NEW YORK – Novartis on Monday said it plans to submit positive data to regulators next year in the hopes of netting another approval for Pluvicto (lutetium vipivotide tetraxetan) as an earlier treatment option for patients with prostate-specific membrane antigen (PSMA)-positive advanced prostate cancer.

The radiopharmaceutical is already approved for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) patients who previously received both an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy. Novartis is now interested in garnering approval for Pluvicto for PSMA-positive advanced prostate cancer patients after they get an ARPI but not taxane-based chemo.

The data Novartis plans to discuss and submit to the US Food and Drug Administration in 2023 comes from the ongoing Phase III PSMAfore trial, which randomized 470 patients to receive either Pluvicto or a change in ARPI therapy. According to Novartis, Pluvicto has met the trial's primary endpoint of improved radiographic progression-free survival. The firm plans to detail the findings at an upcoming medical meeting.

"With the announcement of these positive top-line Phase III results, Pluvicto becomes the first PSMA-targeted radioligand therapy to demonstrate significant and clinically meaningful benefits for people living with this type of prostate cancer who have not received taxane-based chemotherapy," Shreeram Aradhye, Novartis chief medical officer and president of global drug development, said in a statement. "We look forward to discussing the data with healthcare authorities in order to bring this innovative new early treatment option to many more prostate cancer patients sooner after their diagnosis."