April 2022: The Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced Accelerator Applications USA, Inc., a Novartis company) 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.
On the same day, the FDA approved Locametz (gallium Ga 68 gozetotide), a radioactive diagnostic agent for positron emission tomography (PET) of PSMA-positive lesions, including selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated. Locametz is the first radioactive diagnostic agent approved for patient selection in the use of a radioligand therapeutic agent.
Varwere vane mCRPC yakamborapwa vanofanirwa kusarudzirwa kurapwa naPluvicto vachishandisa Locametz kana imwe yakatenderwa PSMA-11 yekufungidzira agent yakavakirwa paPSMA kutaura mumamota. PSMA-positive mCRPC yakatsanangurwa seine kanenge kamwe bundu lesion ine gallium Ga 68 gozetotide kutora yakakura kupfuura yakajairika chiropa. Varwere vakanga vasingabatanidzwi kubva pakunyoresa kana chero maronda anopfuura mamwe saizi maitiro muakisi pfupi aive nekutora zvishoma pane kana kuenzana nekutora muchiropa chakajairika.
Kubudirira kwakaongororwa muVISION (NCT03511664), randomized (2: 1), multicenter, open-label test iyo yakaongorora Pluvicto pamwe nepamusoro pehutano hwehutano (BSoC) (n = 551) kana BSoC chete (n = 280) muvarume vane inofambira mberi, PSMA-positive mCRPC. Vese varwere vakagamuchira analog yeGnRH kana vaive nekutanga bilateral orchiectomy. Varwere vaifanirwa kunge vakagamuchira imwe AR pathway inhibitor, uye 1 kana 2 isati yasvika taxane-based chemotherapy regimens. Varwere vakagamuchira Pluvicto 7.4 GBq (200 mCi) mavhiki matanhatu ega ega kusvika kuhuwandu hwemadhasi matanhatu pamwe neBSoC kana BSoC chete.
Muedzo wakaratidza kuvandudzwa kwakakosha mumagumo ekutanga ekupona kwese (OS) uye radiographic kufambira mberi-kusina kupona (rPFS). Hazard ratio (HR) yeOS yaive 0.62 (95% CI: 0.52, 0.74; p <0.001) pakuenzanisa kwePluvicto pamwe neBSoC maringe neBSoC. Median OS yaive mwedzi 15.3 (95% CI: 14.2, 16.9) muPluvicto plus BSoC ruoko uye 11.3 mwedzi (95% CI: 9.8, 13.5) muruoko rweBSoC, zvichiteerana. Kududzirwa kwehukuru hweiyo rPFS mhedzisiro yaive shoma nekuda kwehupamhi hwepamusoro hwekuongorora kubva pakutanga kudonha kunze kweruoko rwekudzora.
Maitiro akajairika akajairika (≥20%) anoitika pachiitiko chepamusoro muvarwere vaigamuchira Pluvicto vaive kuneta, muromo wakaoma, kusvotwa, kupererwa neropa, kuderera kwechido, uye kuvimbiswa. Kusakwana kwakawanda murabhoritari kwakawedzera kubva pakutanga mu ≥30% yevarwere vaigamuchira Pluvicto kwakadzikira lymphocytes, kuderera kwehemoglobin, kuderera kweleukocyte, kuderera kweplatelet, kuderera kwecalcium, uye kuderera kwesodium. Kurapa nePluvicto kunogona kukonzera njodzi kubva pakufumurwa nemwaranzi, myelosuppression, uye huturu hwerenal. Iyo yekuchengetedza yekutevera nguva muVISION yakanga isina kukwana kutora kunonoka kwemwaranzi-inosanganiswa nehupfu.
Iyo yakakurudzirwa Pluvicto dose ndeye 7.4 GBq (200 mCi) mutsinga mavhiki matanhatu ega ega kusvika ku6 dosi, kana kusvika kufambira mberi kwechirwere kana muchetura usingagamuchirike.
View full prescribing information for Pluvicto. View full prescribing information for Locametz.
