Ua hoʻolaha ʻo Novartis i kēia lā ua ʻae ka US Food and Drug Administration (FDA) i ka Pluvicto ™ (lutetium Lu 177 vipivotide tetraxetan) (i kapa ʻia ma mua ʻo 177Lu-PSMA-617) no ka mālama ʻana i nā poʻe maʻi makua me kekahi ʻano maʻi maʻi maʻi i kapa ʻia prostate- ʻO ka membrane kūikawā antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) i laha i nā wahi ʻē aʻe o ke kino (metastatic). Ua mālama ʻia kēia mau maʻi me nā lāʻau lapaʻau anti-cancer ʻē aʻe (ka hoʻopaʻa ʻana i ke ala o ka receptor androgen a me ka chemotherapy-based chemotherapy).

"ʻO ka ʻae ʻana o Pluvicto kahi holomua lapaʻau koʻikoʻi no nā poʻe me ka holomua mCRPC, no ka mea hiki iā ia ke hoʻomaikaʻi nui i nā helu ola no ka poʻe i kaupalena ʻia nā koho lapaʻau," wahi a Oliver Sartor, MD, Luna Hoʻokele ma Tulane Cancer Center. "He ʻanuʻu ʻo Pluvicto i mua i ka ulu ʻana o ka lāʻau lapaʻau pololei no ka maʻi maʻi prostate."

ʻO Pluvicto ka mua o ka FDA-approved targeted radioligand therapy (RLT) no nā poʻe maʻi kūpono me ka mCRPC e hoʻohui i kahi pūhui huli (ligand) me kahi radioisotope lapaʻau (he ʻāpana radioactive)1. Manaʻo ʻia e loaʻa ʻo Pluvicto i nā kauka a me nā maʻi i loko o nā pule.

Ua ʻae pū ka FDA iā Locametz® (kit no ka hoʻomākaukau ʻana i ka gallium Ga 68 gozetotide injection)2. Ma hope o ka radiolabeling, hiki ke hoʻohana ʻia kēia mea hana kiʻi no ka ʻike ʻana i nā liona maikaʻi PSMA i nā poʻe maʻi makua me ka mCRPC ma o ka positron emission tomography (PET) scan2. ʻO Gallium-68 i kapa ʻia ʻo Locametz hiki ke ʻike i nā ʻeha maʻi e hōʻike ana i ka biomarker PSMA a ʻimi i kahi i laha ʻia ai nā ʻōpū o ke kino (e laʻa, i loko o ka ʻiʻo palupalu, nā lymph nodes, a i ʻole ka iwi), e ʻike ana i nā poʻe maʻi i kūpono no ka mālama ʻana me Pluvicto1,2. Hōʻike nui ʻia ʻo PSMA ma mua o 80 pakeneka o nā mea maʻi me ka maʻi maʻi prostate, e lilo ia i mea biomarker phenotypic koʻikoʻi no ka loiloi ʻana i ka holomua o ka maʻi maʻi prostate metastatic10. Loaʻa ʻia ʻo Locametz i nā kauka a me nā maʻi i loko o nā pule.

"Me kā mākou hoʻolālā kūʻokoʻa e hoʻoponopono i ka maʻi kanesa ma o ka hoʻohana ʻana i ʻehā mau kahua lapaʻau, hauʻoli wau me Pluvicto, ke lawe mai nei mākou i ka platform RLT i manaʻo ʻia no ka mālama ʻana i nā maʻi kūpono me ka mCRPC," wahi a Susanne Schaffert, PhD, Pelekikena, Novartis Oncology. "Ke kūkulu nei ka ʻae o kēia lā ma luna o kā mākou mōʻaukala i ka maʻi maʻi prostate, kahi maʻi hōʻino kahi i manaʻoʻiʻo ai mākou hiki i kā mākou hana hou ke hoʻololi i nā mea maʻi."

Hoʻokumu ʻia ka ʻae ʻana o FDA iā Pluvicto ma nā hopena o ka hoʻāʻo ʻana o ka Phase III VISION i hōʻike ʻia ua mālama ʻia nā mea maʻi ma mua o ka PSMA-positive mCRPC me ka androgen receptor (AR) pathway inhibition a me ka chemotherapy-based chemotherapy i loaʻa iā Pluvicto me ke kūlana o ka mālama (SOC). ke ola holoʻokoʻa i hoʻohālikelike ʻia me SOC wale nō1. He 38% ka emi ʻana o ka pilikia o ka make a me ka hōʻemi nui ʻana o ka hopena o ka maʻi radiographic a i ʻole ka make (rPFS) i hoʻohālikelike ʻia me SOC wale nō. Ua kaupalena ʻia ka wehewehe ʻana i ka nui o ka hopena rPFS ma muli o ke kiʻekiʻe kiʻekiʻe o ka censoring mai ka hāʻule mua ʻana i ka lima mana.

Eia kekahi, ma kahi o kahi hapakolu (30%) o nā maʻi me ka maʻi loiloi ma ka baseline i hōʻike i kahi pane holoʻokoʻa (ma RECIST 1.1) me Pluvicto me SOC, i hoʻohālikelike ʻia me 2% i ka SOC wale nō arm1. ʻO nā hanana pōʻino maʻamau (nā māka āpau) ma ka lima Pluvicto o ke aʻo ʻana he luhi (43%), waha maloʻo (39%), nausea (35%), anemia (nā helu koko ʻulaʻula haʻahaʻa) (32%), emi iho. makemake (21%), a me ka constipation (20%).

He aha e lawe ʻia mai kēia ʻatikala:

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.