Jan 2022: Ga manya marasa lafiya waɗanda ke da ciwace-ciwacen cikin gida wanda ba a sake su ba ko kuma cututtukan ƙwayar cuta na ƙwayar cuta ta perivascular epithelioid cell, Hukumar Abinci da Magunguna ta ba da lasisi. sirolimus furotin da ke daure don dakatarwar allurar (albumin-bound) (Fyarro, Aadi Bioscience, Inc.) (PEComa).
Efficacy was tested in 31 patients with locally advanced unresectable or metastatic malignant PEComa in AMPECT (NCT02494570), a multicenter, single-arm clinical study. On days 1 and 8 of each 21-day cycle, patients received 100 mg/m2 sirolimus protein-bound particles until disease progression or intolerable toxicity.
Yawan amsa gabaɗaya (ORR) da tsawon lokacin amsawa (DOR) sune mahimman matakan sakamako na tasiri, kamar yadda aka ƙaddara ta hanyar nazari mai zaman kanta mai zaman kanta ta amfani da RECIST v.1.1. ORR ya kasance 39 bisa dari (95 bisa dari CI: 22 bisa dari, 58 bisa dari), tare da marasa lafiya biyu sun amsa gaba daya. Ba a cika matsakaicin DOR ba (kashi 95 na CI: watanni 6.5, ba ƙima ba). Kashi 67 cikin 12 na masu amsa sun sami amsa wanda ya wuce fiye da watanni 58, kuma kashi 24 cikin XNUMX sun sami amsa wanda ya wuce fiye da watanni XNUMX.
Stomatitis, gajiya, kurji, kamuwa da cuta, tashin zuciya, edema, gudawa, rashin jin daɗi na musculoskeletal, rage kiba, rage cin abinci, tari, amai, da dysgeusia sune abubuwan da suka fi faruwa a gefe (kashi 30). Ragewar ƙwayoyin lymphocytes, ƙara yawan glucose, raguwar potassium, rage phosphate, rage haemoglobin, da haɓakar lipase sune mafi yawan abubuwan da suka fi dacewa a cikin dakin gwaje-gwaje 3 zuwa 4 (6%).
Har sai cutar ta ci gaba ko rashin jurewa mai guba, shawarar da aka ba da shawarar ita ce 100 mg/m2 da aka ba a matsayin jiko na IV akan mintuna 30 akan kwanaki 1 da 8 na kowane zagaye na kwanaki 21.
Click this link for full prescribing information for Fyarro.
