8月2022： FDA承認の検査で間葉上皮移行（MET）エクソン14スキッピングを引き起こす変異が腫瘍に検出された転移性非小細胞肺がん（NSCLC）の成人患者に対し、食品医薬品局はカプマチニブ（タブレクタ）を投与した。 、Novartis Pharmaceuticals Corp.）の正規承認。
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 腺癌、16%には中枢神経系への転移が見られました。以前に治療を受けた患者の 81% は 16 種類の全身療法しか受けていませんでした。 3% は 86 件を受け取りました。 XNUMX% は XNUMX 件を受け取りました。以前に治療を受けた患者のXNUMX％がプラチナベースの化学療法を受けていました。
患者は、浮腫、吐き気、筋骨格痛、倦怠感、嘔吐、呼吸困難、咳、食欲減退を最も頻繁に経験しました (20%)。
カプマチニブは、食事の有無にかかわらず、400 mg の用量で XNUMX 日 XNUMX 回経口摂取する必要があります。
Enhertuの完全な処方情報を表示します。
