Novartis ngumumake dina iki yen US Food and Drug Administration (FDA) nyetujoni Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) (biyen diarani 177Lu-PSMA-617) kanggo perawatan pasien diwasa kanthi jinis kanker maju tartamtu sing diarani prostat- kanker prostat antigen-positif metastatik antigen-positif kanker prostat (PSMA-positif mCRPC) sing wis nyebar menyang bagean awak liyane (metastatik). Pasien kasebut wis diobati karo perawatan anti-kanker liyane (inhibisi jalur reseptor androgen lan kemoterapi adhedhasar taxane).

"Persetujuan Pluvicto minangka kemajuan klinis sing penting kanggo wong kanthi mCRPC sing maju, amarga bisa ningkatake tingkat kaslametan kanggo wong sing duwe pilihan perawatan sing winates," ujare Oliver Sartor, MD, Direktur Medis ing Pusat Kanker Tulane. "Pluvicto minangka langkah maju ing evolusi obat presisi kanggo kanker prostat."

Pluvicto minangka terapi radioligan target (RLT) sing disetujoni FDA pisanan kanggo pasien sing layak karo mCRPC sing nggabungake senyawa penargetan (ligan) karo radioisotop terapeutik (partikel radioaktif)1. Pluvicto samesthine bakal kasedhiya kanggo dokter lan pasien sajrone sawetara minggu.

FDA uga wis nyetujoni Locametz® (kit kanggo nyiapake injeksi gallium Ga 68 gozetotide)2. Sawise radiolabeling, agen imaging iki bisa digunakake kanggo ngenali lesi positif PSMA ing pasien diwasa kanthi mCRPC liwat scan2 tomografi emisi positron (PET). Gallium-68 kanthi label Locametz bisa ngenali lesi tumor sing nyatakake biomarker PSMA lan nemokake ngendi tumor ing awak bisa nyebar (contone, ing jaringan alus, kelenjar getah bening, utawa balung), ngenali pasien sing layak kanggo perawatan sing ditargetake karo Pluvicto1,2. PSMA banget dituduhake ing luwih saka 80 persen pasien kanker prostat, dadi biomarker fenotipik sing penting kanggo ngevaluasi perkembangan kanker prostat metastatik10. Locametz samesthine bakal kasedhiya kanggo dokter lan pasien sajrone sawetara minggu.

"Kanthi strategi unik kanggo ngatasi kanker kanthi nggunakake papat platform terapeutik, aku seneng banget karo Pluvicto, kita nggawa platform RLT sing ditargetake kanggo nambani pasien sing layak karo mCRPC," ujare Susanne Schaffert, PhD, Presiden, Novartis Oncology. "Dina iki disetujoni dibangun ing sajarah kita ing kanker prostat, penyakit ngancurake ngendi kita pracaya inovasi kita bisa nggawe prabédan migunani kanggo patients."

Persetujuan FDA kanggo Pluvicto adhedhasar asil uji coba Tahap III VISION sing nuduhake manawa pasien mCRPC positif PSMA sing sadurunge diobati karo penghambatan jalur reseptor androgen (AR) lan kemoterapi adhedhasar taxane sing nampa Pluvicto plus standar perawatan (SOC) wis apik. kaslametané sakabèhé dibandhingake SOC piyambak1. Peserta sing diobati karo Pluvicto plus SOC ngalami pengurangan risiko pati 38% lan nyuda risiko penyakit radiografik utawa pati (rPFS) sing signifikan sacara statistik dibandhingake karo SOC mung1. Interpretasi magnitudo efek rPFS diwatesi amarga tingkat censoring sing dhuwur saka awal drop out ing lengen kontrol.

Kajaba iku, udakara katelu (30%) pasien sing nandhang penyakit sing bisa dievaluasi ing awal nuduhake respon sakabèhé (saben RECIST 1.1) karo Pluvicto plus SOC, dibandhingake karo 2% ing SOC mung arm1. Efek samping sing paling umum (kabeh kelas) ing lengen Pluvicto sinau yaiku lemes (43%), tutuk garing (39%), mual (35%), anemia (jumlah sel darah merah rendah) (32%), nyuda napsu (21%), lan constipation (20%).

APA sing kudu dijupuk saka ARTIKEL INI:

Novartis announced today that the US Food and Drug Administration (FDA) approved Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) for the treatment of adult patients with a certain type of advanced cancer called prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) that has spread to other parts of the body (metastatic).
FDA approval of Pluvicto is based on the results of the Phase III VISION trial which demonstrated that PSMA-positive mCRPC patients previously treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy who received Pluvicto plus standard of care (SOC) had improved overall survival compared to SOC alone1.
Participants treated with Pluvicto plus SOC had a 38% reduction in risk of death and a statistically significant reduction in the risk of radiographic disease progression or death (rPFS) compared to SOC alone1.