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How PLUVICTO May Help

Prescribing Information

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Live Support Is Available

Call Novartis Patient Support at

1-888-NOW-NOVA
(1-888-669-6682)

Mon-Fri: 8 AM-8 PM ET

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about PLUVICTO?

Use of PLUVICTO involves exposure to radioactivity. Long-term, accruing radiation exposure is associated with an increased ris...

What is PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan)?

PLUVICTO is a radiopharmaceutical used to treat adults with an 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), and
has...

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Survival Outcomes
Response to Treatment

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Overall Survival

Men with PSMA+ mCRPC who received PLUVICTO plus best standard of care (BSoC) lived a median of 4 months longer: 15.3 months vs 11.3 months with BSoC alone.

The PLUVICTO clinical study measured overall survival (OS). This is the total time men with metastatic prostate cancer were alive from the start of treatment. Median OS is the length of time half of the men were still alive.

In a study of 831 men with PSMA+ metastatic prostate cancer, 551 were treated with PLUVICTO once every 6 weeks (up to 6 treatments) plus BSoC as determined by their doctor. Another 280 were treated with BSoC alone.

Radiographic Progression-Free Survival

Men treated with PLUVICTO plus BSoC lived longer without their cancer growing or spreading—a median of 8.7 months compared with 3.4 months when only on BSoC.

Comparison of rPFS results should be interpreted with caution due to high rates of early dropout in control arm (BSoC alone)

Radiographic Progression-Free Survival with PLUVICTO and BSoC is 8.7 months versus 3.4 months with BSoC alone.

The PLUVICTO clinical study measured radiographic progression-free survival (rPFS). This is the length of time men in the study lived with PSMA+ mCRPC without it spreading or getting worse. Median rPFS is the length of time when half of the men were still alive without their cancer spreading or getting worse.

Overall Response Rate

Almost 30% of men treated with PLUVICTO plus BSoC had their tumors shrink or disappear, compared with 2% of those who received BSoC alone.

The PLUVICTO clinical study measured complete response (CR), which is the disappearance of tumors, and partial response (PR), which is the decrease in the size of tumors. Overall response rate (ORR) is the total percentage of men in a treatment group who had a CR plus the total percentage of men in a treatment group who had a PR.

PSA response

The PLUVICTO clinical study measured the percentage of men who had a 50% drop in prostate-specific antigen (PSA) level from where it started.

46% of men treated with PLUVICTO + BSoC had their PSA level drop by at least half, compared to 7% of those treated with BSoC alone

PSA response was not the primary objective of the study and may not have an impact on overall survival (OS) or radiographic progressive-free survival (rPFS).

For example, if PSA was 100 ng/mL before the clinical trial, then the study would measure if PSA levels would drop to 50 ng/mL or lower.

BSoC, best standard of care; mCRPC, metastatic castration-resistant prostate cancer; PSMA+, prostate-specific membrane antigen positive.

Next: What to Expect When Taking PLUVICTO