DARMSTADT, Germany--(BUSINESS WIRE)--Merck, a leading science and technology company, today announced the latest research from the Company’s oncology portfolio and pipeline to be presented at this year’s European Society of Medical Oncology (ESMO) Annual Meeting, September 9-13, 2022. A total of 29 abstracts, including 5 late-breaking oral presentations and 2 additional mini-oral presentations, will feature data from company- and investigator-sponsored studies across six approved or investigational medicines in multiple tumor types.
Merck Europe B.V. Tepmetko(tepotinib) Receives Approval in Europe
ROCKLAND, Mass.--(BUSINESS WIRE)--EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that the European Commission (EC) has approved once-daily oral TEPMETKO® (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
DARMSTADT, Germany--(BUSINESS WIRE)--Merck, a leading science and technology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of once-daily oral TEPMETKO® (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. The CHMP positive opinion will now be reviewed by the European Commission (EC), with a decision expected in the first quarter of 2022.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has conditonally authorised Merck’s MET inhibitor Tepmetko (tepotinib) for the treatment
EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced research from Company-sponsored, investigator-sponsored, and collaborative studies — including two oral and two mini-oral presentations — at this year’s World Conference on Lung Cancer, September 8-14, 2021, and the European Society for Medical Oncology (ESMO) Congress, September 16-21, 2021.
TOKYO and XIAMEN, China, Aug. 17, 2021 (GLOBE NEWSWIRE) -- Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., (“AmoyDx”) and Precision Medicine Asia Co., Ltd. (“PREMIA”) today announced that the Ministry of Health, Labour and Welfare (MHLW) has approved the AmoyDx® Pan Lung Cancer PCR Panel (the “AmoyDx PLC Panel”) as a companion diagnostic for TEPMETKO® (tepotinib) a Merck KGaA, Darmstadt, Germany product that received approval by the Japanese MHLW in March 2020. TEPMETKO (tepotinib) is approved for use in patients with unresectable, advanced or recurrent non-small cell lung cancer with MET gene exon 14 skipping alterations.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a positive scientific opinion for Merck’s tepotinib for the treatment of advanced non-small cell lung cancer (NSCLC) with METex14 skipping alterations.
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
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