Julij 2021: Breyanzi (Lisocabtagene maraleucel; liso-cel), nov CD19-usmerjen himerni antigenski receptor (CAR) Zdravljenje s T celicami ki ga je razvil Bristol Myers Squibb (BMS), je odobrila ameriška uprava za hrano in zdravila (USFDA).
CAR-T celična terapija je nekakšna imunoterapija, ki deluje tako, da spremeni T celice osebe, da prepozna in uniči rakave celice.
Breyanzi, novo zdravljenje celic T s himernim antigenskim receptorjem (CAR) s CD19, ki ga je razvil Bristol Myers Squibb (BMS), je odobril Ameriška agencija za hrano in zdravila (USFDA) (Lisocabtagene maraleucel; liso-cel).
Preberite tudi: CAR T-Cell terapija v Indiji
Odrasli bolniki z relapsom ali neodzivno (R/R) velikim B-celičnim limfomom (LBCL) po dveh ali več linijah sistemske terapije bodo zdravljeni z novim CAR T celična terapija. There are several types of LBCL, such as primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, follicular lymphoma grade 3B, and DLBCL not otherwise described, which can also develop from indolent lymphoma.
Rak DLBCL je najpogostejša vrsta ne-Hodgkinovega limfoma (NHL) in je agresivna bolezen, pri kateri se 73 odstotkov bolnikov ne odzove na zdravljenje ali se ponovi.
Breyanzi pa ni priporočljiv za bolnike s primarnim limfomom centralnega živčnega sistema, kljub dejstvu, da gre za potencialno kurativno zdravljenje.
Preberite tudi: CAR T-Cell terapija na Kitajskem
Breyanzi, a CAR T celična terapija, will be very important in clinical practice, giving people with relapsed or refractory large B-cell lymphoma the chance for a long-lasting response with a personalized treatment experience, said Samit Hirawat, chief medical officer at Bristol Myers Squibb. Our unwavering commitment to advancing cell therapy research, providing breakthrough medicines, and supporting patients at every step of their treatment journey is reflected in the FDA approval.”
Breyanzi je imel 73 -odstotno skupno stopnjo odziva in 54 -odstotno stopnjo popolnega odziva (CR) v študiji TRANSCEND NHL 001, kar je bilo največje ključno preskušanje pri 3L+ LBCL.
BMS’ imunoterapija manufacturing plant in Bothell, Washington, will produce the novel cell treatment.
CAR T-Cell terapija v Indiji is in the clinical trials stage, and hopefully it will be available very soon for commercial use.
