{"entity":{"id":"merck-kgaa","kind":"company","name":"Merck KGaA (EMD Serono)","aka":["EMD Serono","EMD Serono, Inc.","EMD Serono Research & Development Institute, Inc.","Merck Healthcare KGaA","Merck KGaA, Darmstadt, Germany","Merck Serono"],"tldr":"Merck KGaA of Darmstadt, which trades as EMD Serono in North America, sells the anti-PD-L1 antibody avelumab, cetuximab outside the United States and the MET inhibitor tepotinib, and bought SpringWorks Therapeutics in 2025 to add nirogacestat and mirdametinib for rare tumours.","summary":"Merck KGaA, the Darmstadt science and technology company that is distinct from the US Merck & Co., runs its healthcare business as EMD Serono in the United States and Canada. Its oncology medicines include avelumab (Bavencio), an anti-PD-L1 antibody used as maintenance in urothelial cancer and in Merkel cell carcinoma; cetuximab (Erbitux), which it markets outside North America; and tepotinib (Tepmetko) for MET exon 14-skipping non-small-cell lung cancer. In 2025 it acquired SpringWorks Therapeutics, bringing the gamma-secretase inhibitor nirogacestat for desmoid tumours and the MEK inhibitor mirdametinib for neurofibromatosis-related plexiform neurofibromas. Company facts are from FDA approval records and the SpringWorks acquisition announcement.","asOf":"2026-09-11","wikipedia":"https://en.wikipedia.org/wiki/Merck_Group","links":[{"label":"FDA: oncology and hematologic malignancies approval notifications","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}],"tags":["fda-oce-applicant"],"related":[],"cancers":["urothelial","merkel-cell-carcinoma","nsclc","colorectal","head-and-neck","desmoid-tumour"],"sections":["immunotherapy","targeted-therapy"],"technologies":[],"targets":[],"drugs":["avelumab","cetuximab","capmatinib-tepotinib","nirogacestat","mirdametinib","precemtabart-tocentecan"],"companies":["springworks"],"institutions":[],"pathways":[],"terms":[],"trials":["nct02864992","nct06710132","nct03815643","nct05327530"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor websites)","editedOn":"2026-09-11"},"hq":"Darmstadt","country":"DE","companyType":"pharma","website":"https://www.merckgroup.com","stage":"public","investors":[],"funding":[]},"route":"/companies/merck-kgaa/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"desmoid-tumour","kind":"cancer","name":"Desmoid tumour","route":"/cancers/desmoid-tumour/"},{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"merkel-cell-carcinoma","kind":"cancer","name":"Merkel cell carcinoma","route":"/cancers/merkel-cell-carcinoma/"},{"id":"met-altered-nsclc","kind":"cancer","name":"MET exon 14 and MET-amplified non-small-cell lung cancer","route":"/cancers/met-altered-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"section":[{"id":"immunotherapy","kind":"section","name":"Immunotherapy","route":"/fronts/immunotherapy/"},{"id":"targeted-therapy","kind":"section","name":"Targeted Therapy","route":"/fronts/targeted-therapy/"}],"drug":[{"id":"avelumab","kind":"drug","name":"Avelumab","route":"/drugs/avelumab/"},{"id":"capmatinib-tepotinib","kind":"drug","name":"Capmatinib & tepotinib","route":"/drugs/capmatinib-tepotinib/"},{"id":"cetuximab","kind":"drug","name":"Cetuximab","route":"/drugs/cetuximab/"},{"id":"mirdametinib","kind":"drug","name":"Mirdametinib","route":"/drugs/mirdametinib/"},{"id":"nirogacestat","kind":"drug","name":"Nirogacestat","route":"/drugs/nirogacestat/"},{"id":"precemtabart-tocentecan","kind":"drug","name":"Precemtabart tocentecan","route":"/drugs/precemtabart-tocentecan/"},{"id":"tepotinib","kind":"drug","name":"Tepotinib","route":"/drugs/tepotinib/"},{"id":"xevinapant","kind":"drug","name":"Xevinapant","route":"/drugs/xevinapant/"}],"company":[{"id":"abbisko","kind":"company","name":"Abbisko Therapeutics","route":"/companies/abbisko/"},{"id":"springworks","kind":"company","name":"SpringWorks Therapeutics (Merck KGaA)","route":"/companies/springworks/"},{"id":"threshold-pharmaceuticals","kind":"company","name":"Threshold Pharmaceuticals","route":"/companies/threshold-pharmaceuticals/"}],"trial":[{"id":"nct07170644","kind":"trial","name":"A Study of Nirogacestat in Japanese Adults With Desmoid Tumors/Aggressive Fibromatosis (DT/AF)","route":"/trials/nct07170644/"},{"id":"proceade-crc-03","kind":"trial","name":"A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)","route":"/trials/proceade-crc-03/"},{"id":"nct05327530","kind":"trial","name":"A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)","route":"/trials/nct05327530/"},{"id":"nct03815643","kind":"trial","name":"Avelumab Program Rollover Study","route":"/trials/nct03815643/"},{"id":"nct07004413","kind":"trial","name":"Continuous or Intermittent Cetuximab Plus FOLFIRI as First-line Treatment in RAS/BRAF Wild-type mCRC Patients","route":"/trials/nct07004413/"},{"id":"extreme","kind":"trial","name":"EXTREME","route":"/trials/extreme/"},{"id":"javelin-bladder-100","kind":"trial","name":"JAVELIN Bladder 100","route":"/trials/javelin-bladder-100/"},{"id":"javelin-hn-100","kind":"trial","name":"JAVELIN Head and Neck 100","route":"/trials/javelin-hn-100/"},{"id":"opus","kind":"trial","name":"OPUS","route":"/trials/opus/"},{"id":"nct06710132","kind":"trial","name":"Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)","route":"/trials/nct06710132/"},{"id":"nct07499362","kind":"trial","name":"Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)","route":"/trials/nct07499362/"},{"id":"nct02864992","kind":"trial","name":"VISION (tepotinib)","route":"/trials/nct02864992/"}],"technology":[{"id":"downstream-purification-chromatography","kind":"technology","name":"Downstream purification (Protein A capture, viral clearance, polishing)","route":"/technologies/downstream-purification-chromatography/"},{"id":"single-use-bioprocessing","kind":"technology","name":"Single-use bioprocessing systems","route":"/technologies/single-use-bioprocessing/"},{"id":"adc-supply-chain","kind":"technology","name":"The ADC supply chain (antibody, payload-linker, conjugation, fill)","route":"/technologies/adc-supply-chain/"}]}}