I-FDA igunyaza ukwelashwa kwe-radioligand okuhlosiwe okokuqala komdlavuza wendlala yesinye

A BAMBA MahhalaRelease 6 | eTurboNews | eTN
Isithombe sikaLinda Hohnholz
Ibhalwe ngu Linda Hohnholz

U-Novartis umemezele namuhla ukuthi i-US Food and Drug Administration (FDA) igunyaze i-Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) (phambilini ebibizwa ngokuthi i-177Lu-PSMA-617) yokwelashwa kweziguli ezikhulile ezinohlobo oluthile lomdlavuza osezingeni eliphezulu olubizwa nge-prostate- Ulwelwesi oluthile lwe-antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) olusabalele kwezinye izingxenye zomzimba (metastatic). Lezi ziguli sezivele zelashwa ngezinye izindlela zokwelapha umdlavuza (i-androgen receptor pathway inhibition kanye ne-taxane-based chemotherapy).

"Ukugunyazwa kwe-Pluvicto kuyintuthuko ebalulekile yomtholampilo kubantu abane-mCRPC ethuthukayo, njengoba ingathuthukisa kakhulu amazinga okusinda kulabo abanezinketho zokwelashwa ezilinganiselwe," kusho u-Oliver Sartor, MD, uMqondisi Wezokwelapha e-Tulane Cancer Center. "I-Pluvicto iyigxathu eliya phambili ekuthuthukisweni kwemithi enembile yomdlavuza wendlala yesinye."

I-Pluvicto ingeyokuqala egunyazwe yi-FDA yokwelapha i-radioligand (RLT) ezigulini ezifanele ezine-mCRPC ehlanganisa isakhi esiqondiwe (i-ligand) ne-radioisotope yokwelapha (izinhlayiya ezinomsakazo)1. I-Pluvicto kulindeleke ukuthi itholakale kodokotela neziguli phakathi namasonto.

I-FDA iphinde yagunyaza i-Locametz® (ikhithi yokulungisa umjovo we-gallium Ga 68 gozetotide)2. Ngemva kokukhishwa kwe-radiolabeling, le ejenti yokuthwebula ingase isetshenziselwe ukuhlonza izilonda ezine-PSMA-positive ezigulini ezikhulile ezine-mCRPC ngokusebenzisa i-positron emission tomography (PET) scan2. I-Gallium-68 ebhalwe ukuthi Locametz ingakwazi ukuhlonza izilonda zesimila eziveza i-biomarker ye-PSMA futhi ithole ukuthi izimila zomzimba kungenzeka zisabalele kuphi (isb., ezicutshini ezithambile, ama-lymph nodes, noma ithambo), ihlonze iziguli ezifanelekela ukwelashwa okuhlosiwe nge-Pluvicto1,2. I-PSMA ivezwa kakhulu ngaphezu kwamaphesenti angama-80 eziguli ezinomdlavuza wendlala yesinye, okwenza kube i-phenotypic biomarker ebalulekile yokuhlola ukuqhubeka komdlavuza we-metastatic prostate10. I-Locametz kulindeleke ukuthi itholakale kodokotela neziguli kungakapheli amasonto.

"Ngesu lethu eliyingqayizivele lokubhekana nomdlavuza ngokusebenzisa izinkundla ezine zokwelapha, ngiyajabula ukuthi nge-Pluvicto, siletha inkundla ye-RLT ehlosiwe yokwelapha iziguli ezifanele nge-mCRPC," kusho uSusanne Schaffert, PhD, uMongameli, i-Novartis Oncology. “Ukugunyazwa kwanamuhla kwakhela phezu komlando wethu womdlavuza wendlala yesinye, isifo esibi lapho sikholelwa ukuthi ukusungulwa kwethu kungenza umehluko obonakalayo ezigulini.”

Ukugunyazwa kwe-FDA kwe-Pluvicto kusekelwe emiphumeleni yokuhlolwa kwe-Phase III VISION ebonise ukuthi iziguli ze-PSMA-positive mCRPC ngaphambilini zelashwe nge-androgen receptor (AR) pathway inhibition kanye ne-taxane-based chemotherapy eyathola i-Pluvicto plus standard of care (SOC) yayithuthukile. ukusinda sekukonke uma kuqhathaniswa ne-SOC iyodwa1. Ababambiqhaza abalashwe nge-Pluvicto plus SOC babe nokwehliswa okungama-38% engcupheni yokufa kanye nokuncipha okuphawulekayo kwezibalo engcupheni yokuqhubeka kwesifo se-radiographic noma ukufa (rPFS) uma kuqhathaniswa ne-SOC iyodwa1. Ukuhunyushwa kobukhulu bomphumela we-rPFS kukhawulelwe ngenxa yezinga eliphezulu lokucutshungulwa kusukela ekuphumeni kusenesikhathi engalweni yokulawula.

Ukwengeza, cishe ingxenye eyodwa kwezintathu (30%) yeziguli ezinesifo esilinganiselwa ekuqaleni zibonise impendulo iyonke (nge-RECIST 1.1) nge-Pluvicto kanye ne-SOC, uma kuqhathaniswa no-2% ku-SOC iyodwa ingalo1. Izehlakalo ezimbi ezivame kakhulu (wonke amabanga) engalweni ye-Pluvicto yocwaningo ukukhathala (43%), umlomo owomile (39%), isicanucanu (35%), i-anemia (izibalo zamangqamuzana abomvu egazi aphansi) (32%), ukuncipha. isifiso sokudla (21%), nokuqunjelwa (20%).

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Isithombe sikaLinda Hohnholz

Linda Hohnholz

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