新药COPIKTRA（Duvelisib）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.
2018年9月24日，美国食品和药物管理局(FDA)批准Duvelisib（商品名 COPIKTRA，Verastem公司）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。
  此外，Duvelisib在至少两次之前的系统治疗后，为复发或难治性滤泡性淋巴瘤（FL）的成年患者接受了加速批准。
  CLL和SLL的指征是基于随机、多中心、开放标记试验（NCT02004522）比较复发或难治性CLL或SLL患者Duvelisib和ofatumab。试验随机患者（1:1）口服DuviiSb 25mg，每日2次或奥伐单抗。以300mg的初始剂量静脉注射奥法单抗，一周后再注射2000mg每周一次，7次剂量，然后每4周注射2000mg 4次额外剂量。
  在接受至少2种先前疗法的196名患者中（95名随机分配给Duvelisib，101名随机分配给ofatumab），根据独立审查委员会（IRC）的评估，估计的无进展生存率中位数Duvelisib臂为16.4个月，ofatumumab臂为9.1个月（危险比为0）。40；标准误差0.2）。Duvelisib臂和ofatumab臂每IRC总有效率分别为78%和39%(差异39%,标准差6.5%)。
  FL指征基于Duvelisib(NCT02204982)的单臂多中心试验，纳入83例对利妥昔单抗和化疗或放射免疫治疗无效的FL患者。IRC测定的ORR为42%（95%CI：31，54），41%的患者有部分反应，1例患者有完全反应。35例有效患者中，15例（43%）持续反应至少6个月，6例（17%）持续反应至少12个月。
  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。
  处方信息包含关于致命和/或严重感染、腹泻或结肠炎、皮肤反应和肺炎的方框警告和中性粒细胞减少和肝毒性的警告。442例血液系统恶性肿瘤患者经批准剂量达维利西治疗后，65%出现严重不良反应，最常见的是感染、腹泻或结肠炎和肺炎。
  适应症与用途
  慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）
  COPIKTRA用于治疗复发或难治性CLL或SLL的成年患者在至少两次治疗前。
  最常见的不良反应（发生率≥20%）为腹泻或结肠炎、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。不良反应导致35%例Duvisib永久停药，24%例出现剂量减少。
  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。

完整说明书附件：http://www.copiktrarems.com/wp-content/pdf/COPIKTRA-Prescribing-Information.pdf
Copiktra(Duvelisi Capsules)
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