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How does Pluvicto work?
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) works as a radioligand therapeutic agent. Here are the key details provided on its mechanism of action:
- It binds to prostate-specific membrane antigen (PSMA), a transmembrane protein that is overexpressed on the surface of prostate cancer cells.
- The radioactive lutetium-177 payload emits beta radiation which disrupts cancer cell DNA, causing cell death and tumor regression.
- The localized radiation from lutetium-177 has a penetration range in tissue of up to 2 mm, delivering targeted radiation to PSMA-positive tumors while minimizing effects on surrounding normal tissue.
- By selectively accumulating in and irradiating prostate cancer cells expressing PSMA, Pluvicto attacks the tumor while avoiding unnecessary radiation exposure that can limit the efficacy and tolerability of traditional radiation therapy options.
So in summary, Pluvicto leverages a targeted radioligand therapy approach, using the PSMA protein on prostate cancer cells to deliver radioactive lutetium-177 directly to tumors while minimizing off-target effects, unlike traditional external beam radiation therapy.
What is the life expectancy with Pluvicto?
Efficacy data from clinical trials related to overall survival:
- In the phase 3 VISION trial of Pluvicto, patients treated with Pluvicto plus standard of care had a median overall survival of 15.3 months compared to 11.3 months in the standard of care only group.
- This indicates that adding Pluvicto significantly prolongs overall survival – by about 4 months in this study’s patient population.
- However, individual patient life expectancy could vary substantially depending on specific disease characteristics and how an individual patient responds to treatment.
So while the clinical trial data shows an improvement in median overall survival, it does not provide definitive conclusions about expected life expectancy after being treated with Pluvicto. Prognosis is affected by many patient-specific factors. The degree of life extension also depends on when in a patient’s disease course they receive Pluvicto treatment.
Who manufactures Pluvicto?
- Manufacturer: Advanced Accelerator Applications USA, Inc.
- Trademarks owned by: Novartis AG
- US distributor: Advanced Accelerator Applications USA Inc.
What is Pluvicto used for?
Pluvicto is specifically indicated:
“for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.”NOVARTIS
In other words:
- It is used to treat prostate cancer that has spread to other parts of the body (metastatic) and no longer responds to testosterone suppression therapy (castration-resistant).
- It is intended for patients whose prostate cancer tests positive for PSMA, a protein on the surface of prostate cancer cells that Pluvicto targets.
- Patients should have already been treated with both anti-androgen therapy (AR pathway inhibition) and taxane chemotherapy before receiving Pluvicto.
So in summary, Pluvicto is a radiopharmaceutical agent used to specifically treat advanced, metastatic castration-resistant prostate cancer in patients who meet those additional criteria related to prior treatments and PSMA-positive disease.
When was Pluvicto approved?
Pluvicto was initially approved in the United States in the year 2022.
To give some more specific details on its approval history:
- Pluvicto received Accelerated Approval from the U.S. Food and Drug Administration (FDA) on March 23, 2022.
- It was approved well ahead of the FDA’s assigned Prescription Drug User Fee Act goal date of September 3, 2022, suggesting the priority review due to the unmet need it addresses.
So in summary, Pluvicto received its initial FDA approval, specifically Accelerated Approval status, on March 23rd, 2022, after undergoing priority review as a new radiopharmaceutical agent for the treatment of prostate cancer.
Who developed Pluvicto?
Available information points to likely significant roles by both Advanced Accelerator Applications and Novartis in its R&D and commercialization journey from early conception through regulatory approval and market availability.