Augusti 2022: För vuxna patienter med metastaserad icke-småcellig lungcancer (NSCLC) vars tumörer har en mutation som resulterar i att mesenkymal-epitelial övergång (MET) hoppar över exon 14, som upptäckts av ett FDA-godkänt test, gav Food and Drug Administration capmatinib (Tabrecta, Novartis Pharmaceuticals Corp) regelbundet godkännande.
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, and 16% had metastases to the central nervous system. 81% of patients who had previously had treatment had only gotten one line of systemic therapy; 16% had received two; and 3% had received three. 86% of patients who had previously had treatment had platinum-based chemotherapy.
Patienterna upplevde ödem, illamående, muskel- och skelettsmärta, trötthet, kräkningar, dyspné, hosta och minskad aptit mest frekvent (20 %).
Capmatinib ska tas oralt två gånger dagligen i en dos på 400 mg, med eller utan måltider.
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