- Drug Coverage
- Hypertrophic Cardiomyopathy (HCM)
- Vaccines: 2023 Year in Review
- Eyecare
- Urothelial Carcinoma
- Women's Health
- Hemophilia
- Heart Failure
- Vaccines
- Neonatal Care
- NSCLC
- Type II Inflammation
- Substance Use Disorder
- Gene Therapy
- Lung Cancer
- Spinal Muscular Atrophy
- HIV
- Post-Acute Care
- Liver Disease
- Pulmonary Arterial Hypertension
- Safety & Recalls
- Biologics
- Asthma
- Atrial Fibrillation
- Type I Diabetes
- RSV
- COVID-19
- Cardiovascular Diseases
- Breast Cancer
- Prescription Digital Therapeutics
- Reproductive Health
- The Improving Patient Access Podcast
- Blood Cancer
- Ulcerative Colitis
- Respiratory Conditions
- Multiple Sclerosis
- Digital Health
- Population Health
- Sleep Disorders
- Biosimilars
- Plaque Psoriasis
- Leukemia and Lymphoma
- Oncology
- Pediatrics
- Urology
- Obstetrics-Gynecology & Women's Health
- Opioids
- Solid Tumors
- Autoimmune Diseases
- Dermatology
- Diabetes
- Mental Health
FDA Approves Novartis’ Pluvicto for Advanced Prostate Cancer
Pluvicto is the first targeted radioligand therapy for treatment of progressive, PSMA-positive metastatic castration-resistant prostate cancer.
The FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (mCRPC).
Pluvicto (formerly referred to as 177Lu-PSMA-617) is the first FDA-approved targeted radioligand therapy for eligible patients with mCRPC that combines a targeting compound with a therapeutic radioisotope. Pluvicto is expected to be available to physicians and patients within weeks.
The FDA has also approved a complementary diagnostic imaging agent, Locametz, after radiolabeling with gallium-68 for the identification of PSMA-positive lesion. After radiolabeling, this imaging agent may be used to identify PSMA-positive lesions in adult patients with mCRPC through a positron emission tomography scan.
PSMA is highly expressed in more than 80% of patients with prostate cancer, making it an important phenotypic biomarker for assessing the progression of metastatic prostate cancer. Locametz is expected to be available to physicians and patients within weeks.
Oliver Sartor, M.D.
“The approval of Pluvicto is an important clinical advancement for people with progressing mCRPC, as it can significantly improve survival rates for those who have limited treatment options,” Oliver Sartor, M.D., medical director at Tulane Cancer Center, said in a press release. “Pluvicto is a step forward in the evolution of precision medicine for prostate cancer.”
The approval is based on the results of the phase 3 VISION trial, which demonstrated Pluvicto plus standard of care had a 38% reduction in risk of death and a statistically significant reduction in the risk of radiographic disease progression or death compared with stand of care alone.
Two pivotal phase 3 studies evaluating Pluvicto in earlier lines of treatment for metastatic prostate cancer are under way, with a goal to move into earlier stages of disease.
Pluvicto and Locametz are registered products of Advanced Accelerator Applications, the radioligand business of Novartis.
Using the 'Pathway' Approach to Shorten the Time Between Cancer Diagnosis and Treatment
November 16th 2022In this episode of Tuning In to the C-Suite, Briana Contreras, editor with Managed Healthcare Executive spoke with Dr. Yuri Fesko, oncologist and vice president of Medical Affairs at Quest Diagnostics. In the conversation, Dr. Fesko addressed the ongoing issue of long gaps of times between receiving a diagnosis for a type of cancer and finally getting the treatment for it. Dr. Fesko shared the benefits a number of sectors receive when treating patients sooner and the steps to get there.
Listen
