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FDA Approves TEPMETKO® as the First and Only Once-daily Oral MET Inhibitor for Patients with Metastatic NSCLC with METex14 Skipping Alterations

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ROCKLAND, Mass., Feb. 3, 2021 /PRNewswire/ EMD Serono, the healthcare business sector of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that the US Food and Drug Administration (FDA) has approved TEPMETKO
® (tepotinib) following Priority Review for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (
MET) exon 14 skipping alterations. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
The approval is based on results from the pivotal Phase II VISION study evaluating TEPMETKO as monotherapy in patients with advanced NSCLC with ....

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Merck KGaA, Darmstadt, Germany Announces Update on the INTR@PID Clinical Program Including Lung 037 Study

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Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced an update on the Phase III [email protected] Lung 037 study and the extensive [email protected] clinical trial program for the potential first-in-class investigational bifunctional immunotherapy bintrafusp alfa, in difficult-to-treat cancers, including biliary tract cancer (BTC) and cervical cancer.
The comprehensive [email protected] program is designed to assess the impact of bintrafusp alfa across distinct cancers and settings where TGF-β is thought to play a driving role. TGF-β is a cytokine that is known to be associated with tumor propagation and metastatic potential such as local immunosuppression, fibrosis, growth of tumor blood vessels and chemo- or radiotherapy resistance through several mechanisms. Trapping TGF-β in the tumor microenvironment on top of PD-L1 blockade is thought to be transformative in different clinical settings. ....

United States , Andreas Cezanne , Data Monitoring Committee , Group Website , Clinical Trial Program , Merck Kga , Global Head Of Development For The Healthcare , Merck Kgaa , United Kingdom Based , Independent Data Monitoring Committee , Danny Bar Zohar , Global Head , New Clinical , Biliary Tract Cancer , Non Small Cell Lung Cancer , Clinical Trial , ஒன்றுபட்டது மாநிலங்களில் , ஆண்ட்ரியாஸ் சிஇஇசட்ஏஎன்என்இ , தகவல்கள் கண்காணிப்பு குழு , குழு இணையதளம் , மருத்துவ சோதனை ப்ரோக்ர்யாம் , மெர்க் க்க , உலகளாவிய தலை ஆஃப் வளர்ச்சி க்கு தி சுகாதாரம் , ஒன்றுபட்டது கிஂக்டம் அடிப்படையிலானது , சுயாதீனமான தகவல்கள் கண்காணிப்பு குழு , டேனி மதுக்கூடம் ஜோஹார் ,