BREAKTHROUGH EXPANSION FOR PROSTATE CANCER THERAPY
Novartis has announced a significant development in prostate cancer treatment with the FDA‘s expanded approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan). This radioligand therapy is now available for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have undergone androgen receptor pathway inhibitor (ARPI) therapy and wish to postpone chemotherapy.
This expanded indication dramatically increases patient eligibility by approximately threefold, offering hope to many more individuals battling advanced prostate cancer.
IMPRESSIVE CLINICAL RESULTS
The FDA’s decision stems from the Phase III PSMAfore trial, where Pluvicto demonstrated remarkable efficacy:
- 59% reduction in risk of radiographic progression or death compared to changing ARPI therapy
- More than doubled median radiographic progression-free survival (11.6 months vs. 5.6 months)
- Favorable overall survival trends when adjusted for patient crossover from control arm to Pluvicto
“The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC. It offers a targeted therapy that better delays disease progression compared to a second ARPI,” stated Dr. Michael Morris, Prostate Cancer Section Head at Memorial Sloan Kettering Cancer Center and US Principal Investigator for the study.
SAFETY PROFILE AND PATIENT BENEFITS
Pluvicto demonstrated a consistent and favorable safety profile throughout clinical testing. Most reported adverse events were mild to moderate (Grade 1-2), including:
- Dry mouth (61%)
- Fatigue (53%)
- Nausea (32%)
- Constipation (22%)
Importantly, Pluvicto treatment did not compromise patients’ ability to receive subsequent chemotherapy when needed, preserving future treatment options.
ADDRESSING CRITICAL TREATMENT GAPS
Prostate cancer claims over 35,000 lives annually in the US, with rising incidence rates. Half of mCRPC patients don’t survive long enough to receive second-line treatments, highlighting the urgent need for effective earlier interventions.
While hormone therapy and chemotherapy remain essential treatments, they aren’t appropriate for all patients. Many patients and their healthcare providers prefer avoiding or delaying chemotherapy due to side effects, and clinical guidelines recommend against using multiple ARPIs in sequence.
A MILESTONE FOR PATIENT ADVOCACY
“With worsening outcomes after each successive line of treatment, patients with this type of metastatic prostate cancer and their families have long faced limited options and uncertain outcomes,” said Gina Carithers, CEO and President of the Prostate Cancer Foundation. “The now expanded approval of Pluvicto is an empowering development for the prostate cancer community.”
NOVARTIS COMMITMENT TO RADIOLIGAND THERAPY
“Today’s approval for an expanded indication for Pluvicto brings more choice to nearly three times as many patients, enabling us to further establish radioligand therapies as a pillar in cancer care,” said Victor Bultó, President US, Novartis.
As pioneers in radioligand therapy, Novartis remains committed to providing education, resources, and practical solutions to healthcare providers, ensuring all eligible patients navigating this challenging disease can access appropriate treatment options.
This expanded approval represents a significant advancement in the prostate cancer treatment landscape, offering new hope and options for patients at a critical stage of their cancer journey.
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