US FDA: Takeda Pharmaceutical’s Lung Cancer Treatment Approval: Exkivity
[September 15, Reuters]
Takeda Pharmaceutical Company:
On September 15, it announced that “a drug for the treatment of non-small cell lung cancer, which is a type of lung cancer, has been approved by the FDA.”
Exkivity (generic name: mobocertinib):
Approved is Exkivity (generic name: mobocertinib)
In 114 patients with non-small cell lung cancer,
In Phase 1 and 2 clinical trials
It has been shown to sustain meaningful effects.
The median duration of response in the trial was about 18 months.
Patients receiving lung cancer chemotherapy:
Specifically, it is called “EGFR exon 20 insertion”.
Diagnosed as non-small cell lung cancer with genetic mutation,
Cancer has progressed or received chemotherapy,
Approved for use in patient treatment.
Reuters
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/