Abriil 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.
Bukaanka hore loo daaweeyay mCRPC waa in loo doortaa daawaynta Pluvicto iyadoo la isticmaalayo Locametz ama wakiilka sawir-qaadista ee PSMA-11 ee la ansixiyay oo ku salaysan muujinta PSMA ee burooyinka. PSMA-positive mCRPC waxaa lagu qeexay inuu leeyahay ugu yaraan hal buro oo leh gallium Ga 68 gozetotide qaadashada ka weyn beerka caadiga ah. Bukaan-socodka ayaa laga saaray is-diiwaangelinta haddii dhaawac kasta oo ka sarreeya cabbirka cabbirka qaarkood ee dhidibka gaaban uu qaatay wax ka yar ama la mid ah qaadashada beerka caadiga ah.
Waxtarka waxaa lagu qiimeeyay VISION (NCT03511664), kala soocan (2:1), xarun badan, tijaabo sumad furan oo lagu qiimeeyay Pluvicto oo lagu daray heerka ugu wanaagsan ee daryeelka (BSoC) (n=551) ama BSoC keligiis (n=280) ragga qaba horumarsan, PSMA-positive mCRPC. Dhammaan bukaannada waxay heleen analoog GnRH ama hore ayaa loo sameeyay orchiectomy laba geesood ah. Bukaan-socodka ayaa looga baahnaa in ay helaan ugu yaraan hal-xakameeyaha dariiqa AR, iyo 1 ama 2 ka hor hababka daaweynta kiimikaad ee ku saleysan taxanatiga. Bukaan-socodka ayaa helay Pluvicto 7.4 GBq (200 mCi) 6 toddobaad kasta ilaa wadarta 6 qiyaasood oo lagu daray BSoC ama BSoC oo keliya.
Tijaabadu waxay muujisay horumar la taaban karo oo xagga xisaabaadka ah ee ku aaddan dhammaadka aasaasiga ah ee badbaadada guud (OS) iyo horu-kaca shucaaca badbaadada xorta ah (rPFS). Saamiga khatarta (HR) ee OS wuxuu ahaa 0.62 (95% CI: 0.52, 0.74; p<0.001) marka la barbardhigo Pluvicto iyo BSoC iyo BSoC. Dhexdhexaadinta OS waxay ahayd 15.3 bilood (95% CI: 14.2, 16.9) ee Pluvicto iyo BSoC cudud iyo 11.3 bilood (95% CI: 9.8, 13.5) ee cududda BSoC, siday u kala horreeyaan. Fasiraadda baaxadda saamaynta rPFS ayaa xaddidan sababtoo ah faafreeb heer sare ah oo ka yimid goor hore oo ka dhacday gacanta kantaroolka.
Dareen-celinta xun ee ugu caansan (≥20%) ee ku dhaca dhacdooyinka sare ee bukaanada qaata Pluvicto waxay ahaayeen daal, af qalalan, lallabbo, dhiig-yaraan, rabitaanka cuntada oo yaraada, iyo calool-istaagga. Cilladaha shaybaarka ee ugu caansan ee ka sii dartay asalka ≥30% bukaannada qaata Pluvicto waxay ahaayeen lymphocytes oo hoos u dhacay, hoos u dhaca hemoglobin, hoos u dhaca leukocytes, platelets oo hoos u dhaca, hoos u dhaca calcium, iyo hoos u dhaca sodium. Daawaynta Pluvicto waxa laga yaabaa inay ka dhalato khatarta soo-gaadhista shucaaca, myelosuppression, iyo sunta kelyaha. Muddada dabagalka badbaadada ee VISION kuma filna in la qabto sunta shucaaca la xidhiidha.
Qiyaasta Pluvicto ee lagu taliyey waa 7.4 GBq (200 mCi) xididka 6 toddobaad kasta ilaa 6 qiyaasood, ama ilaa uu cudurku ka sii socdo ama sunta aan la aqbali karin.
View full prescribing information for Pluvicto. View full prescribing information for Locametz.
