2022 avgust: Odraslim bolnikom z metastatskim nedrobnoceličnim pljučnim rakom (NSCLC), katerih tumorji imajo mutacijo, ki povzroči preskok eksona 14 mezenhimsko-epitelijskega prehoda (MET), kar je odkrilo s testom, ki ga je odobrila FDA, je Urad za hrano in zdravila dal kapmatinib (Tabrecta , Novartis Pharmaceuticals Corp.) redna odobritev.
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, 16 % pa jih je imelo metastaze v centralnem živčnem sistemu. 81 % bolnikov, ki so bili predhodno zdravljeni, je prejelo samo eno linijo sistemske terapije; 16 % jih je prejelo dva; 3 % pa jih je prejelo tri. 86 % bolnikov, ki so bili predhodno zdravljeni, je imelo kemoterapijo na osnovi platine.
Najpogosteje so se pri bolnikih pojavili edem, slabost, mišično-skeletna bolečina, utrujenost, bruhanje, dispneja, kašelj in zmanjšan apetit (20 %).
Kapmatinib je treba jemati peroralno dvakrat na dan v odmerku 400 mg, s hrano ali brez nje.
Oglejte si vse informacije o predpisovanju zdravila Enhertu.
