{"id":66925,"date":"2026-06-01T14:00:05","date_gmt":"2026-06-01T06:00:05","guid":{"rendered":"https:\/\/flcube.com\/?p=66925"},"modified":"2026-06-01T14:00:06","modified_gmt":"2026-06-01T06:00:06","slug":"mercks-calderasib-pembrolizumab-combination-receives-fda-breakthrough-therapy-designation-for-first-line-kras-g12c-mutant-nsclc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=66925","title":{"rendered":"Merck’s Calderasib-Pembrolizumab Combination Receives FDA Breakthrough Therapy Designation for First-Line KRAS G12C-Mutant NSCLC"},"content":{"rendered":"\n

Merck & Co., Inc. (MSD; NYSE: MRK<\/a>)<\/strong> announced that the U.S. Food and Drug Administration (FDA)<\/strong> has granted Breakthrough Therapy designation (BTD)<\/strong> to calderasib (MK-1084)<\/strong>, an investigational oral KRAS G12C inhibitor<\/strong>, in combination with KEYTRUDA (pembrolizumab)<\/strong> for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC)<\/strong> harboring KRAS G12C mutations<\/strong> and expressing PD-L1 (tumor proportion score [TPS] \u22651%)<\/strong>. The designation was supported by positive data from the Phase 1 KANDLELIT-001 trial<\/strong> and accelerates Merck’s entry into the rapidly evolving KRAS-targeted therapy market.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Agency<\/strong><\/td>FDA (United States)<\/td><\/tr>
Designation<\/strong><\/td>Breakthrough Therapy Designation (BTD)<\/td><\/tr>
Company<\/strong><\/td>Merck & Co., Inc. (MSD; NYSE: MRK)<\/td><\/tr>
Drug Combination<\/strong><\/td>Calderasib (MK-1084) + KEYTRUDA (pembrolizumab)<\/td><\/tr>
Indication<\/strong><\/td>First-line advanced\/metastatic NSCLC with KRAS G12C mutation and PD-L1 TPS \u22651%<\/td><\/tr>
Announcement Date<\/strong><\/td>29 May 2026<\/td><\/tr>
Supporting Data<\/strong><\/td>Phase 1 KANDLELIT-001 trial<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Drug Profile & Development Partnership<\/h2>\n\n\n\n