美国 FDA：武田制药的肺癌治疗批准：Exkivity
[路透社 9 月 15 日]
武田制药公司：
9月15日，它宣布“一种治疗非小细胞肺癌的药物已获得FDA批准，这是一种肺癌。”
Exkivity（通用名：mobocertinib）：
批准的是 Exkivity（通用名称：mobocertinib）
在 114 名非小细胞肺癌患者中，
在 1 期和 2 期临床试验中
它已被证明可以维持有意义的效果。
试验中的中位反应持续时间约为 18 个月。
接受肺癌化疗的患者：
具体称为“EGFR外显子20插入”。
诊断为基因突变的非小细胞肺癌，
癌症已经进展或接受化疗，
批准用于患者治疗。
路透社
https://jp.reuters.com/article/takeda-pharmaceutical-fda-idJPKBN2GB2GY
Takeda’s EXKIVITY™ (mobocertinib) Approved by U.S. FDA
as the First Oral Therapy Specifically Designed for Patients with EGFR Exon20 Insertion+
September 15, 2021
Approval based on Phase 1/2 trial results, which demonstrated clinically meaningful responses with a median duration of response (DoR) of approximately 1.5 years
Next-generation sequencing (NGS) companion diagnostic test approved simultaneously to support identification of patients with EGFR Exon20 insertion mutations
OSAKA, Japan, and CAMBRIDGE, Mass. September 15, 2021
Takeda Pharmaceutical Company Limited
today announced that the U.S. FDA) has approved EXKIVITY (mobocertinib) for the treatment of adult patients
with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
EXKIVITY, which was granted priority review and received Breakthrough Therapy Designation,
Fast Track Designation and Orphan Drug Designation from the FDA, is the first and only approved oral therapy specifically designed to target EGFR Exon20 insertion mutations.
This indication is approved
under Accelerated Approval based on overall response rate (ORR) and DoR.Continued approval for this indication
may be contingent upon verification and description of clinical benefit in a confirmatory trial.The approval of EXKIVITY
introduces a new and effective treatment option for patients with EGFR Exon20 insertion+ NSCLC, fulfilling an urgent need for this difficult-to-treat cancer,” said Teresa Bitetti, president, Global Oncology Business Unit, Takeda.
EXKIVITY is the first and only oral therapy
specifically designed to target EGFR Exon20 insertions, and we are particularly encouraged by the duration of the responses observed with a median of approximately 1.5 years.
This approval milestone
reinforces our commitment to meeting the needs of underserved patient populations within the oncology community.
NSCLC
https://www.takeda.com/newsroom/newsreleases/2021/takeda-exkivity-mobocertinib-approved-by-us-fda/