Nuwamba 2023: Elranatamab-bcmm (Elrexfio, Pfizer, Inc.) wani bispecific B-cell maturation antigen (BCMA) -directed CD3 T-cell engager wanda Hukumar Abinci da Magunguna ta ba da izini ga manya tare da sake dawowa ko ɓarna mahara myeloma waɗanda suka sami yana da aƙalla layi huɗu na jiyya, waɗanda suka haɗa da mai hana proteasome, wakili na immunomodulatory, da anti-CD38 monoclonal antibody.
A cikin MagnetisMM-3 (NCT04649359), marasa lafiya tare da relapsed ko refractory MM waɗanda ke da tsayayya ga aƙalla mai hana proteasome guda ɗaya, maganin rigakafi guda ɗaya, da anti-CD38 antibody an haɗa su a cikin buɗaɗɗen lakabin, hannu ɗaya, bincike-bincike da yawa zuwa ga tantance inganci. A lokacin yin rajista, marasa lafiya sun cika sharuddan da Ƙungiyar Ƙwararrun Ƙwararrun Ƙwararru ta Duniya (IMWG) ta gindaya don cutar da ake iya ganowa.
Babban hanyoyin da za a auna yadda wani abu ya yi aiki da kyau shine ƙimar amsawar haƙiƙa (ORR) da kuma tsawon lokacin amsawa (DOR), waɗanda wani mai zaman kansa, makanta na tsakiya ya samo shi yana bin jagororin IMWG. Marasa lafiya casa'in da bakwai waɗanda ba su taɓa karɓar maganin da aka ba da umarnin BCMA ba amma suna da aƙalla layin jiyya huɗu na farko - mai hana proteasome, maganin rigakafi, da anti-CD38 monoclonal antibody — ya zama babban ingancin yawan jama'a. Marasa lafiya casa'in da bakwai (95% CI: 47.3%, 67.7%) a adadin da aka ba da shawarar suna da ORR na 57.7%. Matsakaicin DOR tsakanin masu amsawa ba a kai ba bayan bin watanni 11.1 (95% CI: watanni 12, ba a kai ba). 90.4% (95% CI: 78.4%, 95.9%) shine ƙimar DOR a watanni shida, da 82.3% (95% CI: 67.1%, 90.9%) a watanni tara.
Elranatamab-bcmm’s prescribing information includes a Boxed Warning for neurologic damage, including immune effector cell-associated neurotoxicity (ICANS), and cytokine saki ciwo (CRS), which can be deadly or life-threatening. Elranatamab-bcmm was administered to patients at the prescribed dose; of them, 58% experienced CRS, 59% experienced neurologic damage, and 3.3% experienced ICANS. In 0.5% of individuals, grade 3 CRS happened, while in 7% of cases, grade 3 or 4 neurologic toxicity happened. Elranatamab-bcmm is only accessible through a restricted programme under a Risk Evaluation and Mitigation Strategy (REMS), known as the ELREXFIO REMS, due to the risks of CRS and neurologic toxicity, including ICANS.
CRS, gajiyawa, amsawar wurin allura, gudawa, kamuwa da cuta na numfashi na sama, rashin jin daɗi na tsoka, ciwon huhu, rage cin abinci, kurji, tari, tashin zuciya, da pyrexia sune abubuwan da suka fi faruwa akai-akai (≥20%). Ragewar haemoglobin, neutrophils, platelet, lymphocytes, da fararen jini sune mafi yawan abubuwan da suka fi dacewa a cikin dakin gwaje-gwaje na digiri na 3 zuwa 4 (≥20%).
Maganin farko na 76 MG a ranar 8 yana biye da "mataki-mataki kashi 1" na 12 MG a ranar 1 da "matakin mataki na 2" na 32 MG a ranar 4. Abubuwan da aka ba da shawarar elranatamab-bcmm sune kamar haka : 76 mg mako-mako ta hanyar Makon 24. Ya kamata tazara tazara ta canza zuwa kowane mako biyu ga marasa lafiya waɗanda suka ɗauki elranatamab-bcmm aƙalla makonni 24, sun nuna amsoshi na ɓangare, ko mafi kyau, da ci gaba da amsawa na akalla watanni biyu. Ana iya ɗaukar Elranatamab-bcmm har sai cutar ta yi muni ko kuma matakin guba ya zama mara haƙuri.
