Litaba tsa mohala

FDA e fana ka tumello ea pele ea kalafo ea radioligand bakeng sa mofetše oa senya

ngotsoeng ke mohlophisi

Novartis o phatlalalitse kajeno hore US Food and Drug Administration (FDA) e amohetse Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) (eo pele e neng e bitsoa 177Lu-PSMA-617) bakeng sa kalafo ea bakuli ba baholo ba nang le mofuta o itseng oa mofetše o tsoetseng pele o bitsoang prostate- special membrane antigen-positive metastatic castration-resistant cancer (PSMA-positive mCRPC) e hasaneng likarolong tse ling tsa 'mele (metastatic). Bakuli bana ba se ba ntse ba phekoloa ka liphekolo tse ling tse khahlanong le kankere (androgen receptor pathway inhibition le taxane-based chemotherapy).

"Tumelo ea Pluvicto ke tsoelo-pele ea bohlokoa ea kliniki bakeng sa batho ba nang le mCRPC e ntseng e tsoela pele, kaha e ka ntlafatsa haholo litekanyetso tsa ho phela ho ba nang le mekhoa e fokolang ea phekolo," ho boletse Oliver Sartor, MD, Mookameli oa Bongaka Setsing sa Kankere sa Tulane. "Pluvicto ke mohato o hatelang pele kholisong ea meriana e nepahetseng bakeng sa mofetše oa senya."

Pluvicto ke phekolo ea pele ea radioligand e amohetsoeng ke FDA (RLT) bakeng sa bakuli ba tšoanelehang ba nang le mCRPC e kopanyang motsoako o lebisitsoeng (ligand) le radioisotope ea kalafo (karoloana ea radioactive)1. Pluvicto e lebelletsoe ho fumaneha ho lingaka le bakuli nakong ea libeke.

FDA e boetse e amohetse Locametz® (kit bakeng sa ho lokisa ente ea gallium Ga 68 gozetotide)2. Ka mor'a radiolabeling, mochine ona oa litšoantšo o ka sebelisoa ho khetholla liso tsa PSMA-positive ho bakuli ba baholo ba nang le mCRPC ka positron emission tomography (PET) scan2. Gallium-68 e ngotsoeng Locametz e ka tsebahatsa maqeba a hlahala a hlalosang PSMA biomarker le ho fumana moo lihlahala li ka bang teng 'meleng (mohlala, ka lisele tse bonolo, li-lymph nodes, kapa lesapo), ho khetholla bakuli ba tšoanelehang bakeng sa phekolo e lebisitsoeng ho Pluvicto1,2. PSMA e hlahisoa haholo ho bakuli ba fetang liperesente tse 80 ba nang le mofetše oa tšoelesa ea senya, e leng se etsang hore e be mohloli oa bohlokoa oa phenotypic biomarker bakeng sa ho lekola tsoelo-pele ea mofetše oa tšoelesa ea senya10. Locametz e lebelletsoe ho fumaneha ho lingaka le bakuli nakong ea libeke.

"Ka leano la rona le ikhethileng la ho sebetsana le mofets'e ka ho sebelisa li-platform tse 'ne tsa kalafo, ke thabetse hore ebe ka Pluvicto, re tlisa sethala se lebisitsoeng sa RLT bakeng sa ho phekola bakuli ba tšoanelehang ka mCRPC," ho boletse Susanne Schaffert, PhD, Mopresidente, Novartis Oncology. "Kamohelo ea kajeno e thehiloe nalaneng ea rona ea mofetše oa tšoelesa ea senya, lefu le senyang moo re lumelang hore boqapi ba rona bo ka etsa phapang ea bohlokoa ho bakuli."

Kopano ea maeto a lefats'e ka bophara Mmaraka oa maeto oa Lefatše London o khutlile! Mme o memilwe. Ona ke monyetla oa hau oa ho hokahana le basebetsi-'moho le uena indastering, marang-rang a lithaka, ho ithuta lintlha tsa bohlokoa le ho fihlela katleho ea khoebo ka matsatsi a 3 feela! Ngolisa ho boloka sebaka sa hau kajeno! e tla etsahala ho tloha ka la 7-9 Pulungoana 2022. Ngodisa hona joale!

Tumello ea FDA ea Pluvicto e ipapisitse le liphetho tsa teko ea Phase III VISION e bonts'itseng hore bakuli ba PSMA-positive mCRPC ba kile ba alafshoa ka androgen receptor (AR) pathway inhibition le taxane-based chemotherapy ba fumaneng Pluvicto plus standard of care (SOC) e ntlafetse. ho phela ka kakaretso ha ho bapisoa le SOC feela1. Barupeluoa ba ileng ba phekoloa ka Pluvicto hammoho le SOC ba bile le phokotso ea 38% ea kotsi ea lefu le phokotso e kholo ea lipalo-palo ea kotsi ea tsoelo-pele ea lefu la radiographic kapa lefu (rPFS) ha e bapisoa le SOC feela1. Tlhaloso ea boholo ba phello ea rPFS e ne e lekanyelitsoe ka lebaka la tekanyo e phahameng ea ho thibela ho tloha qalong ea letsoho la taolo.

Ho phaella moo, hoo e ka bang karolo ea boraro (30%) ea bakuli ba nang le lefu le ka lekanyetsoang qalong ba bontšitse karabo e akaretsang (ka RECIST 1.1) le Pluvicto hammoho le SOC, ha e bapisoa le 2% ho SOC feela arm1. Liketsahalo tse mpe tse atileng haholo (limaraka tsohle) letsohong la Pluvicto la thuto e ne e le mokhathala (43%), molomo o omileng (39%), ho nyekeloa ke pelo (35%), phokolo ea mali (lipalo tse tlase tsa lisele tse khubelu tsa mali) (32%), tse fokotsehileng. takatso ea lijo (21%), le pipitlelano (20%).

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mohlophisi

Mohlophisi e moholo oa eTurboNew ke Linda Hohnholz. O lula ntlong e kholo ea eTN e Honolulu, Hawaii.

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