2022 Séptémber: The European Commission (EC) has authorized Kite’s Terapi sél T-mobil Tecartus® (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and older with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukaemia. Kite is a Gilead Company (Nasdaq: GILD) (ALL).
Numutkeun ka Christi Shaw, CEO Kite, "Kalayan persetujuan ieu, Tecartus janten terapi sél T CAR anu munggaran sareng hiji-hijina anu disarankeun pikeun populasi pasien ieu, pikeun nyayogikeun kabutuhan médis anu ageung." Ieu ogé kaopat disatujuan pamakéan terapi sél Layang-layang di Éropa, evideving kaunggulan aranjeunna nyadiakeun keur penderita, utamana maranéhanana kalawan sababaraha alternatif terapi lianna.
The most prevalent type of ALL, which is an aggressive blood malignancy, is B-cell precursor ALL. Annually, ALL is diagnosed in about 64,000 people worldwide. With the current standard-of-care medications, the median overall survival (OS) for individuals with ALL is just about eight months.
According to Max S. Topp, MD, professor and director of haematology at the University Hospital of Wuerzburg in Germany, “adults with relapsed or refractory ALL frequently undergo multiple treatments, including chemotherapy, targeted therapy, and stem cell transplant, creating a significant burden on a patient’s quality of life.” Patients in Europe today benefit from a significant improvement in care. Durable responses from Tecartus point to the possibility of a long-term remission and a novel treatment strategy.
Multiséntral internasional ZUMA-3, panangan tunggal, labél kabuka, panilitian Fase 1/2 pendaptaran pasien dewasa (18 taun) kalayan kambuh atanapi refractory ALL nyayogikeun hasil anu ngadukung persetujuan éta. Kalawan median nurutan-up 26.8 bulan, ulikan ieu némbongkeun yén 71% tina penderita evaluable (n = 55) ngalaman remisi lengkep (CR) atanapi CR kalawan recovery parsial hematological (CRi). Dina set data anu langkung ageung, kasalametan umum median pikeun sadaya pasien anu nampi dosis konci (n = 78) langkung ti dua taun (25.4 bulan), sareng pikeun réspondén, éta ampir opat taun (47 bulan) (pasién anu ngahontal CR. atanapi CRi). Durasi median remisi (DOR) diantara pasien anu efficacy tiasa dievaluasi nyaéta 18.6 bulan.
The safety outcomes among the patients given Tecartus at the target dose (n=100) were consistent with the drug’s known safety profile. 25% and 32% of patients, respectively, experienced grade 3 or higher sindrom sékrési sitokin (CRS) and neurologic adverse events, which were typically adequately controlled.
