Core Concepts
FDA approves Posluma for PET imaging in prostate cancer.
Abstract
The US FDA has approved Posluma, a radiopharmaceutical for PET imaging in prostate cancer. Posluma binds to PSMA, aiding in disease extent evaluation. Available in the US from June 2023. Approval based on two single-arm trials showing high detection rates and minimal adverse events.
FDA Approval of Posluma
FDA approves Posluma for PET imaging in prostate cancer.
Posluma binds to PSMA, aiding in disease extent evaluation.
Availability and Manufacturer
Posluma to be available in the US from June 2023.
Manufactured and distributed by PETNET Solutions.
Comparison with Other Products
Posluma compared to gallium-68 gozetotide for similar indications.
Gozetotide also indicated for metastatic prostate cancer.
Approval Trials and Results
Approval based on two single-arm trials from Blue Earth.
LIGHTHOUSE trial showed low sensitivity but high specificity.
SPOTLIGHT trial demonstrated high detection rates.
Adverse Events and Warnings
Minimal adverse events reported in trials.
Posluma PET contributes to long-term radiation exposure.
Interpretation may vary among readers.
Stats
Posluma binds prostate-specific membrane antigen (PSMA).
Posluma sensitivity for predicting positive nodes ranged from 23% to 30%.
Specificity of Posluma ranged from 93% to 97%.
Adverse events included diarrhea (0.7%), blood pressure increases (0.5%), and injection site pain (0.4%).
Quotes
"The study showed that Posluma PET provided clinically valuable information prior to surgery." - Brian Chapin, MD