米ＦＤＡ：武田薬品の肺がん治療薬を承認：Exkivity（動画）：
US FDA: Takeda Pharmaceutical’s Lung Cancer Treatment Approval: Exkivity:
美国 FDA：武田制药的肺癌治疗批准：Exkivity
［9月15日 ロイター］
武田薬品工業：
9月15日、「肺がんの一種である非小細胞肺がんの治療薬がＦＤＡの承認を受けた」と発表した。
Exkivity（一般名：モボセルチニブ）：
承認されたのはExkivity（一般名：モボセルチニブ）
非小細胞肺がん患者１１４人を対象とする、
臨床第１・２相試験で、
意義のある効果を持続することが示された。
治験での奏功期間の中央値は約１８カ月だった。
肺がん化学療法を受けた患者：
具体的には、「ＥＧＦＲエクソン２０挿入」と呼ばれる。
遺伝子変異を伴う非小細胞肺がんと診断され、
がんが進行したか、化学療法を受けた、
患者向けの治療に使うため承認された。
ロイター
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/