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FDA Grants Fast Track Designation to VS-7375 for KRAS G12D-Mutated Pancreatic Cancer
25 Jul 2025 19:19 GMT
… the potential to address unmet medical needs. The fast track … phase 1/2a clinical trial [NCT07020221], our goal is to … the lack of FDA-approved, KRAS G12D-targeted treatments for people … and in combination with cetuximab (Erbitux). The primary end points …
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Novel Oral KRAS G12D Inhibitor Receives FDA Fast Track Designation in Advanced PDAC
25 Jul 2025 18:55 GMT
… FDA approved an investigational new drug application for VS-7375 in the treatment … /2a VS-7375-101 trial (NCT06500676) that evaluated the safety … ] and in combination with cetuximab [Erbitux] in advanced solid tumors, including …
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ISGIO Conference Highlights Emerging Trial Results Shaping GI Cancer Care
22 Jun 2025 17:49 GMT
… trials, novel drug approvals, and innovative therapeutic combinations are reshaping treatment … (Erbitux) and encorafenib (Braftovi) plus chemotherapy that resulted in FDA … Medical Oncology Gastrointestinal Cancers Congress, presenting a deluge of trial …
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OPC 2025: Early and Metastatic GI Cancers See Practice Changing Trial Results
20 Jun 2025 04:51 GMT
… summarizing recent clinical trial data shaping the treatment landscape for GI …
Despite the lack of FDA approval or formal inclusion … (Braftovi; Pfizer), and cetuximab (Erbitux; Eli Lilly). A third arm … s nice to see negative trials published, because then we …
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Lung Cancer Drugs Shows Promise for Treatment-Resistant Melanoma
11 Jun 2025 19:07 GMT
… NYU Grossman School of Medicine.
EGFR inhibitors are already … researchers tested two drugs from this class, Erbitux (cetuximab) and … with other immunotherapies for treatment of melanoma patients whose … plans to develop clinical trials to test whether these …
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FDA Advances ALX2004 to Phase 1 Trials in EGFR+ Solid Tumors
07 Apr 2025 17:22 GMT
… new drug (IND) application for ALX2004 for the treatment of … dose-expansion, phase 1 trial assessing ALX2004 in EGFR- … which also includes multiple trials evaluating our lead therapeutic … in combination with cetuximab (Erbitux) in patients with colorectal …
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Phase III BREAKWATER Trial Shows Braftovi-Based Regimen Improves Survival in BRAF V600E-Mutant Metastatic Colorectal Cancer
03 Jun 2025 22:34 GMT
… Chemotherapy
In the BREAKWATER trial, the Braftovi + Erbitux + mFOLFOX6 regimen reduced … of Medicine (NEJM), show the combination of Braftovi plus Erbitux (cetuximab … -FDA-Approves-Pfizer%E2%80%99s-BRAFTOVI%C2%AE-Combination-Regimen-as-First-Line-Treatment-of …
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ASCO25: MSD’s KRAS G12C drug shows early promise in Phase I
02 Jun 2025 11:08 GMT
… a manageable safety profile. Treatment-related adverse events (AEs) … in several Phase III trials, including the Phase III … 3% ORR.
Other major pharmaceutical companies have also revealed data … (encorafenib) in combination with Erbitux and mFOLFOX6.
Merck KGaA …
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Precision Pfizer Drug Leads to ‘Unprecedented’ Survival in Colorectal Cancer, Data at ASCO Show
30 May 2025 20:32 GMT
… the New England Journal of Medicine.
Braftovi is a kinase inhibitor … this trial are the confirmatory benchmarks that could support full FDA approval … name Erbitux), an Eli Lilly drug that is a standard treatment for colorectal …
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Pfizer announces positive results from phase 3 BREAKWATER trial of Braftovi in combo with cetuximab & mFOLFOX6 in patients with BRAF V600E─mutant mCRC
02 Jun 2025 07:21 GMT
… trial evaluating Braftovi (encorafenib) in combination with cetuximab (marketed as Erbitux … US Food and Drug Administration (FDA) in December 2024 … , and Africa. Ono Pharmaceutical Co., Ltd. has exclusive … mFOLFOX6, for the treatment of patients with metastatic …
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