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    Association details:
    Biomarker:FOLH1 positive
    Cancer:Prostate Cancer
    Drug:Pluvicto (lutetium Lu 177 vipivotide tetraxetan) (Ionizing radiation emitter, PSMA inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Novartis Press Release
    Title:

    Novartis receives European Commission approval for Pluvicto® as the first targeted radioligand therapy for treatment of progressive PSMA–positive metastatic castration-resistant prostate cancer

    Published date:
    12/13/2022
    Excerpt:
    Novartis today announced the European Commission (EC) approved Pluvicto® (INN: lutetium (177Lu) vipivotide tetraxetan), a targeted radioligand therapy. Pluvicto® is approved in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition, for the treatment of adult patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC).
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Canada Newswire
    Title:

    Health Canada approves PLUVICTO™ as first targeted radioligand therapy for progressive PSMA‑positive metastatic castration-resistant prostate cancer

    Published date:
    09/07/2022
    Excerpt:
    Advanced Accelerator Applications Canada Inc. is pleased to announce that Health Canada has approved PLUVICTO TM (lutetium (177Lu) vipivotide tetraxetan injection) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have received at least one androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    PMLive
    Title:

    Novartis’ Pluvicto receives MHRA marketing authorisation to treat advanced prostate cancer

    Published date:
    08/12/2022
    Excerpt:
    Novartis’ radiogland therapy (RLT) Pluvicto – lutetium Lu 177 vipivotide tetraxetan – has received its first approval in Europe as a treatment for advanced prostate cancer from the Medicines and Healthcare Products Regulatory Agency (MHRA)….The marketing authorisation in Britain is specifically for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)...
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    03/23/2022
    Excerpt:
    PLUVICTO 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.
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Systemic Therapy for M1 CRPC: Adenocarcinoma...Prior docetaxel and prior novel hormone therapy...Useful in certain circumstances...Lutetium Lu 177 vipivotide tetraxetan (Lu-177–PSMA-617) for PSMA-positive metastases (category 1).
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Novartis Press Release
    Title:

    Novartis Pluvicto™ shows statistically significant and clinically meaningful radiographic progression-free survival benefit in patients with PSMA–positive metastatic castration-resistant prostate cancer

    Published date:
    12/05/2022
    Excerpt:
    Novartis announced the pivotal Phase III PSMAfore study with PluvictoTM (INN: lutetium (177Lu) vipivotide tetraxetan), a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, met its primary endpoint. Pluvicto demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) in patients with PSMA–positive metastatic castration-resistant prostate cancer (mCRPC)...
    Trial ID:
    PSMAfore
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Novartis Press Release
    Title:

    Novartis receives positive CHMP opinion for Pluvicto® for patients with progressive, PSMA-positive metastatic castration-resistant prostate cancer

    Published date:
    10/14/2022
    Excerpt:
    Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization for Pluvicto® (INN: lutetium (177Lu) vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617), a radioligand therapy, in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition, for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy....The positive CHMP opinion is based on data from the Phase III VISION study...
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ASCO 2021
    Title:

    Phase III study of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer (VISION)

    Published date:
    05/19/2021
    Excerpt:
    177Lu-PSMA-617 plus SOC treatment is a well-tolerated regimen that improves rPFS and prolongs OS compared with SOC alone in men with advanced-stage PSMA-positive mCRPC.
    Trial ID:
    VISION
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Novartis Press Release
    Title:

    Novartis announces positive result of phase III study with radioligand therapy 177Lu-PSMA-617 in patients with advanced prostate cancer

    Published date:
    03/23/2021
    Excerpt:
    Novartis today reported the first interpretable results of the Phase III VISION study evaluating the efficacy and safety of 177Lu-PSMA-617, a targeted radioligand therapy in patients with progressive PSMA positive metastatic castration-resistant prostate cancer (mCRPC)...The trial met both primary endpoints of overall survival and radiographic progression-free survival.
    Trial ID:
    VISION
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer

    Excerpt:
    ...Overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/standard of care`Overall Survival...
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Soc, Versus SoC Alone, in Adult Male Patients With mHSPC

    Excerpt:
    ...Patients must have evidence of PSMA-positive disease as seen on a 68Ga-PSMA-11 PET/CT scan, and eligible as determined by the sponsor's central reader 7....
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Lancet Oncol
    Title:

    [177Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-arm, phase 2 study

    Published date:
    05/08/2018
    Excerpt:
    Patients underwent a screening PSMA and FDG-PET/CT to confirm high PSMA-expression...radionuclide treatment with [177Lu]-PSMA-617 has high response rates, low toxic effects, and reduction of pain in men with metastatic castration-resistant prostate cancer who have progressed after conventional treatments.
    DOI:
    https://doi.org/10.1016/S1470-2045(18)30198-0