FDA approves Pluvicto for Prostate Cancer

Novartis is a global medicine company using innovative science and digital technologies to create transformative treatments in areas of great medical need, including late-stage prostate cancer.  Today it was announced the Company had received FDA Approval for Pluvicto™, the first targeted radiopharmaceutical therapy (RPT) for treatment of progressive prostate cancer.

Pluvicto (Lutetium-177 vipivotide tetraxetan, commonly known as 177Lu-PSMA-11) is a radioligand therapeutic agent 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.

Approximately 190,000 patients are diagnosed with prostate cancer each year in the U.S.  Of those, it is estimated 50,000 would benefit from a PSMA-based therapy.

In response to this exciting announcement for patients, the Society of Nuclear Medicine and Molecular Imaging has published PSMA Appropriate Use Criteria to accelerate the identification of patients who may benefit from this treatment.

For these patients, dosimetry guided therapy (DG-RPT) enabled by Torch™* software from Voximetry may increase tumor response, improve quality of life and enable longer overall survival.

According to Voximetry CEO, Dr. Sue Wallace, “This is why we started the Company.   We don’t make the radiotherapeutics like Pluvicto, we make them better.   Dosimetry-guided RPT is specifically designed to improve patient outcomes by making it simpler for physicians to develop patient-specific treatment plans.  Personalization has been shown to make RPT therapies safer and more effective”.

Torch simplifies personalized RPT treatment planning with an automated workflow powered by lightning-fast graphics processing units (GPUs) that can provide full Monte Carlo dose assessment in seconds.

About Voximetry:   Voximetry is a Healthtech software company commercializing complex algorithms on high-speed Graphics Processing Units (GPUs). Currently focused on radiation transport science, Voximetry is advancing patient-specific treatment planning in late-stage cancer patients.

*510(k) pending. Torch™ is under FDA review and is NOT Available for Sale or Clinical Use.