2022 kolovoz: Odraslim pacijentima s metastatskim rakom pluća nemalih stanica (NSCLC) čiji tumori imaju mutaciju koja rezultira preskakanjem egzona 14 mezenhimalno-epitelne tranzicije (MET), što je otkriveno testom koji je odobrila FDA, Uprava za hranu i lijekove dala je kapmatinib (Tabrecta , Novartis Pharmaceuticals Corp.) redovito odobrenje.
Capmatinib was given fast approval for the same use on May 6, 2020, based on the overall response rate and length of response in the GEOMETRY mono-1 trial (NCT02414139), a multicenter, non-randomized, open-label, multi-cohort research study. Based on data from an additional 63 patients and an additional 22 months of follow-up to evaluate response durability and confirm therapeutic benefit, the conversion to regular approval was made.
160 patients with advanced NSCLC with a mutation skipping exon 14 of MET showed efficacy. Patients received capmatinib 400 mg twice a day until their disease progressed or the side effects became intolerable.
A Blinded Independent Review Committee (BIRC) determined the ORR and duration of response (DOR) as the major efficacy measures (BIRC). 60 individuals who had never received treatment had an ORR of 68% (95% CI: 55, 80) and a DOR of 16.6 months (95% CI: 8.4, 22.1). The ORR was 44% (95% CI: 34, 54) among 100 patients who had previously received treatment, and the DOR was 9.7 months (95% CI: 5.6, 13).
The patients’ average age was 71 years (48 to 90). The following specific demographics were reported: 61% female, 77% were white, 61% never smoked, 83% had adenokarcinom, a 16% je imalo metastaze u središnji živčani sustav. 81% pacijenata koji su prethodno bili na liječenju dobili su samo jednu liniju sistemske terapije; 16% je primilo dva; a 3% je primilo tri. 86% pacijenata koji su prethodno bili na liječenju imalo je kemoterapiju na bazi platine.
Bolesnici su najčešće imali edem, mučninu, mišićno-koštanu bol, umor, povraćanje, dispneju, kašalj i smanjen apetit (20%).
Kapmatinib treba uzimati oralno dva puta dnevno u dozi od 400 mg, sa ili bez obroka.
Pogledajte sve informacije o propisivanju za Enhertu.
