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Takeda Pharmaceutical Company Limited (Takeda Pharmaceutical Company Limited's,TSE: 4502 / NYSE: TAK ) (referred to as "Takeda") today announced that the US Food and Drug Administration Administration ( the FDA ) has approved during platinum-containing chemotherapy EXKIVITY (mobocertinib) for the treatment or Later , adult patients with locally advanced or metastatic non-small cell lung cancer ( NSCLC ) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (detected by FDA-approved testing)
.
EXKIVITY received FDA priority review, and obtained breakthrough therapy certification, fast track review qualification and orphan drug qualification.
TSE:4502/NYSE:TAK manages FDA NSCLC
Teresa Bitetti, President of Takeda's Global Oncology Division, said: "EXKIVITY's approval to insert EGFR exon 20 + NSCLC patients provides a new and effective treatment option to meet the urgent needs of this refractory cancer.
EXKIVITY is the first This is also the only oral therapeutic drug specifically designed to target the insertion of EGFR exon 20.
We are delighted with the median measured duration of remission of approximately 1.
The FDA also approved Thermo Fisher Scientific's Oncomine Dx Target Test as an NGS companion diagnostic reagent for EXKIVITY to identify NSCLC patients with EGFR exon 20 insertion
.
NGS testing is very important for these patients because it can achieve a more accurate diagnosis and is superior to polymerase chain reaction (PCR) testing.
Accurate diagnosis
Dr.
Pasi A.
Jänne, MD of Dana Farber Cancer Institute said: “EGFR exon 20 insertion + NSCLC is a type of cancer that is underserved and drugged.
We have not been able to use traditional EGFR TKIs.
Effective targeted therapy
.
The approval of EXKIVITY (mobocertinib) marks another important step forward, providing doctors and their patients with a new targeted oral therapeutic drug specifically designed for this patient population.
Marcia Horn, executive leader of the International Cancer Rights Network (ICAN) Exon 20 Group, said: “Patients with EGFR exon 20 insertion + NSCLC have always faced a series of unique challenges.
This type of lung cancer is very rare and not only difficult to make comprehensive Diagnosis, and lack of targeted treatment options that can improve the remission rate
.
As a patient advocate, I have worked with EGFR exon 20 insertion + NSCLC patients and their families every day for the past five years.
The FDA approval is based on the results of a population previously treated with platinum in the EXKIVITY Phase 1/2 trial.
This population includes 114 patients with EGFR exon 20 insertion + NSCLC who have previously received platinum-containing treatment at a therapeutic dose of 160 Milligrams
.
The results of this phase 1/2 trial were presented at the American Society of Clinical Oncology ( ASCO ) 2021 meeting .
American Society of Clinical Oncology ( ASCO ) 2021 ASCO
The most common adverse reactions (>20%) are diarrhea, rash, nausea, stomatitis, vomiting, loss of appetite, paronychia, fatigue, dry skin and musculoskeletal pain
.
EXKIVITY prescribing information includes "boxed warnings" for QTc prolongation and torsade de pointes ventricular tachycardia, as well as warnings and precautions for interstitial lung disease/pulmonary interstitial inflammation, cardiotoxicity, and diarrhea
The FDA review is carried out under the Orbis project.
The Orbis project is an initiative of the FDA Oncology Center of Excellence (OCE), which provides a framework for the simultaneous approval and review of oncology products among international partners
.
We look forward to continuing to collaborate with regulatory authorities in various countries to bring mobocertinib to patients
Delivery of Takeda’s first round of product lines.
Takeda is ready to achieve near-term growth through global brand expansion and its first round of product lines , including a number of similar-to-best/first-in-class new molecular entities (NME )
.
Our second round of product line includes nearly 30 NME and next-generation platforms, which will support Takeda's sustainable growth in fiscal year 2025 and beyond
.
product line
About EXKIVITY (mobocertinib)
EXKIVITY is the first tyrosine kinase inhibitor (TKI) oral therapeutic drug of its kind, specifically designed to selectively target the epidermal growth factor receptor (EGFR) exon 20 insertion mutation
.
EXKIVITY is approved in the United States for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) adult patients with EGFR exon 20 insertion mutations (detected by FDA-approved testing) who have disease progression during or after platinum-containing chemotherapy
.
The China Center for Drug Evaluation (CDE) has also accepted mobocertinib for approval of the Phase 1/2 trial results of locally advanced or metastatic NSCLC patients with EGFR exon 20 insertion mutations who have previously received at least one systemic chemotherapy
.
Regarding EGFR exon 20 insertion + NSCLC
non-small cell lung cancer (NSCLC) is the most common type of lung cancer.
According to the World Health Organization, it accounts for approximately 85% of approximately 2.
2 million newly diagnosed lung cancer cases worldwide 1,2
.
Epidermal growth factor receptor (EGFR) exon 20 insertion + NSCLC accounts for about 1-2% of NSCLC patients, and it is more common in Asian populations than in Western populations 3-7
.
The prognosis of the disease is worse than other EGFR mutants because EGFR TKI-which does not specifically target the insertion of EGFR exon 20-and chemotherapy have limited benefits for these patients
.
1,2 3-7
Takeda is committed to continuing research and development to meet the needs of the lung cancer community by discovering and providing revolutionary drugs
.
EXKIVITY important safety information QTc interval prolongation and torsade de pointes type ventricular tachycardia : EXKIVITY may lead to life-threatening heart rate correction QT (QTc) prolongation, including potentially fatal torsade de pointes type ventricular tachycardia, need to be at baseline and QTc and electrolytes were monitored regularly during treatment .
Patients with prolonged QTc risk factors should increase the frequency of monitoring .
Combination drugs and strong or moderate CYP3A inhibitors that are known to prolong the QTc interval should be avoided in combination with EXKIVITY .
These drugs may further prolong QTc .
According to the severity of QTc extension, EXKIVITY can be suspended, reduced or permanently disabled .
Patients with prolonged QTc risk factors should increase the frequency of monitoring .
Combination drugs and strong or moderate CYP3A inhibitors that are known to prolong the QTc interval should be avoided in combination with EXKIVITY .
These drugs may further prolong QTc .
According to the severity of QTc extension, EXKIVITY can be suspended, reduced or permanently disabled .
Interstitial lung disease (ILD)/pulmonary interstitial inflammation : The patient should be monitored for new or worsening pulmonary symptoms indicative of ILD/pulmonary interstitial inflammation
.
Patients with suspected ILD/pulmonary interstitial inflammation should immediately suspend EXKIVITY.
If ILD/pulmonary interstitial inflammation is diagnosed, EXKIVITY should be permanently discontinued
.
Cardiotoxicity : Heart function should be monitored at baseline and during treatment, including left ventricular ejection fraction
.
According to the severity, it can be suspended, decremented and reused or permanently disabled
.
Diarrhea : Diarrhea can cause dehydration or electrolyte imbalance, with or without kidney damage
.
Electrolytes should be monitored, and patients should be advised to start an antidiarrheal drug and increase fluid and electrolyte intake during the first episode of diarrhea
.
According to severity, EXKIVITY can be suspended, reduced or permanently disabled
.
Embryo-fetal toxicity : The drug can harm the fetus
.
Women of childbearing age should be informed that the drug has potential risks to the fetus and that effective non-hormonal contraceptive measures should be taken
.
cardiotoxic
diarrhea
embryo-fetal toxicity
Takeda’s Commitment to Oncology
Our core R&D mission is to deliver new drugs to cancer patients around the world through our commitment to science, breakthrough innovation, and passion for improving patients’ lives
.
Whether relying on our blood treatment drugs, our strong product pipeline, or solid tumor drugs, our aim is to remain innovative and competitive in order to provide patients with the treatment they need
.
Important Note
For the purposes of this article, "press release" refers to this document, any oral statement, any question-and-answer session, and any written or oral materials discussed or distributed by Takeda Pharmaceutical Co.
, Ltd.
("Takeda") on the content of this press release
.
This press release (including any oral briefings and any questions and answers related thereto) does not constitute, represents, or forms any offer to purchase, and any offer, invitation or solicitation to acquire, register, exchange, sell or dispose of any securities, or Part of soliciting any vote or approval in any jurisdiction
.
No stocks may be offered for public sale by virtue of this press release
.
Unless registered under the US Securities Act of 1933 and its amendments or exempted therefrom, no securities may be placed in the United States
.
This press release (together with any further information that may be provided to the recipient) is only used to provide the recipient with information for reference purposes (not to evaluate any investment, acquisition, disposal or any other transaction)
.
Any failure to comply with the above restrictions may violate applicable securities laws
.
Companies directly or indirectly held by Takeda through investment are independent entities
.
In this press release, sometimes for convenience, "Takeda" is used as a collective term for Takeda and its subsidiaries
.
Similarly, words like "we" (subject and object forms) and "our" are also collective names for subsidiaries or represent employees of the company
.
These expressions are also used in situations that have no practical meaning and do not involve a particular company or certain companies
.
Forward-Looking Statements
This press release and any materials distributed in connection with it may contain forward-looking statements, views or opinions related to Takeda’s future business, future conditions and operating performance, including Takeda’s estimates, forecasts, goals and plans
.
Forward-looking statements often include, but are not limited to, the following words, such as "target", "plan", "believe", "hope", "continue", "anticipate", "intend", "intend", "ensure", " "Will", "may", "should", "will", "maybe", "expect", "estimate", "forecast" or similar expressions or their negative form
.
These forward-looking statements are based on assumptions about many important factors, including the following factors, which may cause actual results to differ materially from those expressed or implied by the forward-looking statements: The economic situation faced by Takeda’s global operations, including Japan and the United States The macroeconomic environment; competitive pressures and developments; changes in applicable laws and regulations; including global medical reforms; inherent challenges in the development of new products, including the uncertainty of clinical success and the timing of decisions or decision-making by regulatory authorities; new products And uncertainty about the commercial success of existing products; manufacturing difficulties or delays; fluctuations in interest rates and exchange rates; claims or questions about the safety or efficacy of sold products or candidate products; health crises such as the new coronavirus pandemic affect Takeda and The impact of its customers and suppliers, including foreign governments in the country in which Takeda operates or other aspects of its business; the timing and impact of post-merger integration efforts of acquired companies; whether it is possible to divest non-core assets of Takeda’s operations and any such Timing of the divestiture; and other factors described in the latest Form 20-F annual report and other reports submitted by Takeda to the US Securities and Exchange Commission.
For details, please refer to the Takeda website https:// Or .
Takeda does not undertake to update any forward-looking statements in this press release or any other forward-looking statements that the company may issue, unless required by law or securities trading rules
.
Historical performance does not represent future performance, and the performance or statement of Takeda in this press release cannot be referred to, nor is it an estimate, forecast, guarantee or speculation of Takeda’s future performance
.
https:// information
The products mentioned in this press release may not be marketed in all countries, or may be sold under different trademarks, or used for different diseases, or in different dosages, or have different effects
.
Any information contained in this article should not be regarded as an application, promotion or advertisement of any prescription drugs, including those drugs under development
.
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, Ltd.
Free Join Cancer Statistics 2020: GLOBOCAN the Estimates of Incidence and Mortality Worldwide 185 for 36 Cancers in the Countries (2020 global cancer statistics: GLOBOCAN global morbidity and mortality in 185 countries, 36 kinds of cancer estimate).
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3 Riess, Jonathan W.
Diverse EGFR Exon 20 Insertions and Co-Occurring Molecular Alterations Identified by Comprehensive Genomic Profiling of NSCLC.
(Through the comprehensive genome analysis of NSCLC, a variety of EGFR exon 20 insertions and co-occurring molecular changes have been identified
.
) https:// Accessed on April 7, 2020
.
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2 https:// cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.
html https:// -non-small-cell-lung-cancer.
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3 https:// https:// 0864(18)30770-6/fulltext
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biomedcentral.
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1186/s12885-019-5820-0 https://bmccancer.
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5
6
7 JAMA leaves a message here