FDA inobvumidza yekutanga yakanangwa radioligand kurapwa kwegomarara reprostate

Novartis azivisa nhasi kuti US Food and Drug Administration (FDA) yakabvumidza Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) (yaimbonzi 177Lu-PSMA-617) kurapwa kwevarwere vakuru vane imwe mhando yegomarara repamusoro rinonzi prostate- chaiyo membrane antigen-positive metastatic castration-resistant cancer prostate (PSMA-positive mCRPC) yakapararira kune dzimwe nhengo dzemuviri (metastatic). Varwere ava vakatorapwa nemamwe marapirwo ekurwisa cancer (androgen receptor pathway inhibition uye taxane-based chemotherapy).

"Kubvumidzwa kwePluvicto kufambira mberi kwakakosha kwekiriniki kune vanhu vane mCRPC inofambira mberi, sezvo inogona kuvandudza zvakanyanya huwandu hwekupona kune avo vane maitiro mashoma ekurapa," akadaro Oliver Sartor, MD, Medical Director kuTulane Cancer Center. "Pluvicto inhanho yekumberi mukushanduka kwemushonga chaiwo wegomarara reprostate."

Pluvicto ndiyo yekutanga FDA-inotenderwa yakanangwa radioligand therapy (RLT) yevarwere vanokodzera vane mCRPC inosanganisa inonangwa komisheni (ligand) neanorapa radioisotope (a radioactive particle)1. Pluvicto inotarisirwa kuwanikwa kuvarapi nevarwere mukati memavhiki.

Iyo FDA yakabvumidzawo Locametz® (kiti yekugadzirira gallium Ga 68 gozetotide jekiseni)2. Mushure mekuita radiolabeling, iyi yekufungidzira inogona kushandiswa kuona PSMA-positive maronda muvarwere vakuru vane mCRPC kuburikidza ne positron emission tomography (PET) scan2. Gallium-68 yakanyorwa kuti Locametz inogona kuona maronda ebundu anoratidza iyo PSMA biomarker uye kuwana panogona kunge akapararira mumuviri mamota (semuenzaniso, munyama yakapfava, lymph nodes, kana bhonzo), kuratidza varwere vanokodzera kurapwa kwakanangwa nePluvicto1,2. PSMA inoratidzwa zvakanyanya mune inopfuura 80 muzana yevarwere vane kenza yeprostate, zvichiita kuti ive yakakosha phenotypic biomarker yekuongorora kufambira mberi kwe metastatic prostate cancer10. Locametz inotarisirwa kuwanikwa kuvarapi nevarwere mukati memavhiki.

"Nechirongwa chedu chakasarudzika chekurwisa cancer nekushandisa mapuratifomu mana ekurapa, ndinofara kuti naPluvicto, tiri kuunza yakanangwa RLT chikuva chekurapa varwere vanokodzera nemCRPC," akadaro Susanne Schaffert, PhD, Mutungamiriri, Novartis Oncology. "Mvumo yanhasi inovakira panhoroondo yedu mugomarara reprostate, hosha inoparadza yatinotenda kuti hunyanzvi hwedu hunogona kuita musiyano unokosha kuvarwere."

Kubvumidzwa kweFDA kwaPluvicto kunobva pane zvakabuda muyedzo yePhase III VISION yakaratidza kuti varwere vePSMA-positive mCRPC vakamborapwa neandrogen receptor (AR) nzira inhibition uye taxane-based chemotherapy avo vakagamuchira Pluvicto plus mwero wekutarisira (SOC) yakanga yavandudzika. kupona kwese kuenzaniswa neSOC chete1. Vatori vechikamu vakarapwa nePluvicto pamwe neSOC vaive ne38% kudzikiswa kwenjodzi yekufa uye kudzikiswa kwakanyanya munjodzi yekuenderera mberi kwechirwere cheradiographic kana kufa (rPFS) zvichienzaniswa neSOC chete1. Dudziro yehukuru hweiyo rPFS mhedzisiro yaive shoma nekuda kwehupamhi hwepamusoro hwekuongorora kubva pakutanga kudonha kunze kweruoko rwekudzora.

Mukuwedzera, inenge chikamu chimwe muzvitatu (30%) yevarwere vane chirwere chinoongororwa pakutanga vakaratidza mhinduro yose (pa RECIST 1.1) nePluvicto pamwe neSOC, zvichienzaniswa ne2% muSOC chete arm1. Zviitiko zvinowanzoitika zvakashata (magiredhi ese) muPluvicto ruoko rwechidzidzo kwaive kuneta (43%), muromo wakaoma (39%), kusvotwa (35%), anemia (yakaderera masero matsvuku eropa) (32%), yakaderera. kuda kudya (21%), uye kuvimbiswa (20%).