2018年9月24日，美国食品和药物管理局（FDA）批准Copiktra（Duvelisib）上市，用于治疗复发或难治性慢性淋巴细胞白血病（CLL）或小淋巴细胞淋巴瘤（SLL）的成年患者，这些患者至少有两种先前的治疗方法。此外，Copiktra还被批准加速批准为复发或难治性滤泡性淋巴瘤（FL）的成年人谁有两种或多种先前的系统治疗。
  淋巴瘤治疗研究基金会的首席执行官Meghan Gutierrez在一份声明中说：“生活在CLL/SLL或FL的患者需要额外的治疗选择，而新的治疗方法如CopikTa至关重要，因为每一位患者的治疗旅程都是独一无二的。”“我们赞赏Verastem Oncology等公司致力于研究和开发这些疗法，以期达到将淋巴瘤作为慢性疾病加以治疗并最终治愈的一天。”
  一个随机，多中心，开放标签试验（NCT020422）导致了CLL和SLL的批准。它以1至1的比例随机接受CopikTrA或Arzerra（OfutuMUMAB）。Copiktra组每天口服25mg药物，而Arzerra组则静脉注射，第一周开始注射300mg，然后每周注射2000mg，每次7次，然后每四周注射2000mg，再注射4次。
  对于196名之前至少接受过两次治疗的患者，在Copiktra臂中估计无进展生存期（PFS）中位数为16.4个月，而在Arzerra臂中估计为9.1个月。Copiktra的总应答率（ORR）为Arzerra的78%和39%。
  对FL患者的加速批准是基于单臂多中心试验（NCT02204982）的结果，该试验包括83名对利妥昔单抗（利妥昔单抗）和化疗或放射免疫治疗无效的患者。试验显示42% ORR，41%的患者有部分反应。甚至有一个病人有完全的反应。
  在35个应答组中，15例（43%）维持了持续六个月或更长时间的应答。6例（17%）患者的反应持续至少12个月。
  FDA在一份声明中写道：“FL指征的持续批准可能取决于在规划的随机试验中证实的临床益处。”
  严重副作用包括：严重感染，腹泻或结肠炎，皮肤反应和肺炎，以及中性粒细胞减少和肝毒性（肝损伤）。接受批准剂量的Copiktra治疗的65%的患者有严重的副作用，最常见的是感染、腹泻或结肠炎和肺炎。
  在至少20%的患者中发生的药物最常见的副作用包括：腹泻或结肠炎、中性粒细胞减少、皮疹、疲劳、发热、咳嗽、恶心、上呼吸道感染、肺炎、肌肉骨骼疼痛和贫血。35%的患者因副作用而停用药物，而24%的患者有剂量减少。
  推荐的DuviiSb剂量为:每天口服两次25毫克，在28天的治疗周期中连续服用。

完整资料附件：
1）：https://www.copiktra.com/
2）：http://www.copiktrarems.com/wp-content/pdf/COPIKTRA-Prescribing-Information.pdf
3）：https://www.drugs.com/newdrugs/fda-approves-copiktra-duvelisib-capsules-chronic-lymphocytic-leukemia-small-lymphocytic-lymphoma-4822.html
COPIKTRA(duvelisib)
COPIKTRA Rx
Generic Name and Formulations:
Duvelisib 15mg, 25mg; caps.
Company:
Verastem Oncology
Indications for COPIKTRA:
Treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least 2 prior therapies. Treatment of adults with relapsed or refractory follicular lymphoma (FL) after at least 2 systemic therapies.
Adult:
Swallow whole. 25mg twice daily in a 28-day cycle. Give PJP prophylaxis during and after completing Copiktra treatment until absolute CD4+ T cell count >200 cells/µL. Concomitant strong CYP3A4 inhibitors (eg, ketoconazole): reduce to 15mg twice daily. Dose modifications: see full labeling.
Children:
Not established.
Boxed Warning:
Fatal and serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis.
Warnings/Precautions:
Risk of serious infections (eg, pneumonia, sepsis, lower respiratory); treat prior to initiation. Monitor for new or worsening signs/symptoms of infection; withhold if Grade ≥3 until resolved; resume at same or lower dose. Withhold if any grade of Pneumocystis jirovecii pneumonia (PJP) suspected; permanently discontinue if confirmed. Consider antiviral prophylaxis for CMV infection/reactivation during therapy. Monitor for new or worsening diarrhea or colitis; if presented, initiate supportive care as appropriate (see full labeling) and monitor at least weekly until resolved; discontinue if life-threatening diarrhea or colitis occurs. Monitor for new or worsening cutaneous reactions; if presented, initiate supportive care as appropriate (see full labeling) and monitor at least weekly until resolved; discontinue if life-threatening reaction occurs or if severe reaction does not improve, worsens, or recurs. Withhold if new or progressive pulmonary signs/symptoms develop; discontinue if severe/life-threatening or if non-infectious pneumonitis recurs or is unresponsive to steroids. Monitor hepatic function during treatment; withhold and monitor at least weekly if Grade 3 ALT/AST elevation (>5–20×ULN) until return to <3×ULN; discontinue if Grade 4 ALT/AST elevation (>20×ULN). Monitor neutrophil counts at least every 2 weeks for the first 2 months and at least weekly if counts <1.0Gi/L; withhold if <0.5Gi/L; monitor until ANC >0.5Gi/L. Embryo-fetal toxicity. Females of reproductive potential and males (w. female partners): use effective contraception during and for at least 1 month after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for at least 1 month after last dose).
Pharmacological Class:
Phosphoinositide 3-kinase (PI3K) inhibitor.
Interactions:
Antagonized by strong CYP3A4 inducers; avoid. Potentiated by strong CYP3A4 inhibitors; reduce dose (see Adults). Potentiates sensitive CYP3A4 substrates; consider reducing dose of these and monitor for toxicities.
Adverse Reactions:
Diarrhea, colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory tract infection, pneumonia, musculoskeletal pain, anemia.
REMS:
YES
Generic Availability:
NO
How Supplied:
Caps—56