1.波士顿时间9月24日,Verastem Oncology 宣布公司的新药COPIKTRA™ (duvelisib) Capsules获得美国FDA批准上市。

https://www.verastem.com/wp-content/uploads/2018/08/prescribing-information.pdf
2.Indications and Usage(适应症)
(1)Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory CLL or SLL after at least two prior therapies.(已经接受过至少两次前期疗法的复发/难治性慢性淋巴性白血病(CLL)和小淋巴细胞淋巴瘤(SLL)成年患者)
(2)Follicular Lymphoma (FL)*
COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory FL after at least two prior systemic therapies.(治疗至少接受过两次前期疗法的复发/难治性滤泡性淋巴瘤(FL)成年患者)
*This indication is approved under accelerated approval based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
3.公司Pipeline:

4.9月25日 Verastem Oncology宣布:CSPC Pharmaceutical Group Limited and Verastem Oncology Sign Exclusive License Agreement for the Development and Commercialization of COPIKTRA™ (duvelisib) in China.
Verastem Oncology将收到1500万美元首付款;额外3000万美元的开发里程金,销售里程碑付款,和两位数的销售净提成。
http://investor.verastem.com/phoenix.zhtml?c=250749&p=irol-newsArticle&ID=2368922
这个交易不知道谈了多久,下手挺快,早前在二级市场可能更便宜! the Oral Inhibitor of Phosphoinositide 3-Kinase (PI3K), and the First Approved Dual Inhibitor of PI3K-delta and PI3K-gamma (PI3K-δ,γ), COPIKTRA (duvelisib)。
参考:
NMPA/FDA;
药融数据,Pharnex Datamonitor;
相关公司公开披露等。

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