Array BioPharma announced positive results from the Phase III BEACON CRC trial evaluating a triple combination of the BRAF inhibitor Braftovi (encorafenib), the MEK inhibitor Mektovia (binimetinib), and the anti-EGFR antibody Erbitux (cetuximab) in patients with advanced BRAFV600E-mutant metastatic colorectal cancer after one or two lines of therapy.
Exelixis’ Late-Stage Melanoma Combination Falls Short in Phase III Trial
Anti-PDL1 Antibodies, BRAF V600 Inhibitors, BRAF V600 wild-type advanced melanoma, Clinical Trials, Colorectal Cancer, Combination Therapies, Melanoma, Monoclonal Antibodies, R&D, Shares, U.S. Securities and Exchange Commission (SEC)Shares of Exelixis fell after the company disclosed in a U.S. SEC filing that a Phase III melanoma trial failed to hit endpoints.
The U.S. Food and Drug Administration approved Novartis AG’s Tafinlar and Mekinist combination therapy to treat an aggressive type of thyroid cancer.
The U.S. FDA granted priority review for Novartis’ Tafinlar in combination with Mekinist for treating some patients with advanced melanoma.
Novartis’ drugs Tafinlar and Mekinist edged closer to approval in Europe to be used together against a type of lung cancer.
Bristol-Myers Squibb Co said the U.S. Food and Drug Administration declined to approve its immuno-oncology drug, Opdivo, for its expanded use to treat an additional type of advanced skin cancer. Bristol-Myers said it received a so-called complete response letter from the health regulator, which indicated the need for additional data in the BRAF mutated patient […]
Roche buoyed by early data on atezolizumab in advanced melanoma
Advanced Melanoma, Bladder Cancer, BRAF Inhibitors, BRAF V600 Inhibitors, Health, Hemophilia, Hemophilia, Immune System, Immune Systems, Lung Cancer, Melanoma, Multiple Sclerosis, Multiple Sclerosis, Potential Blockbusters, R&D, Studies, Targeted Therapies, TherapeuticsSwiss drugmaker Roche released on Monday what it called encouraging early data on cancer drug atezolizumab in combination therapy for treating a form of advanced melanoma. A phase Ib study of atezolizumab (MPDL3280A), used in combination with the BRAF inhibitor Zelboraf for previously untreated BRAFV600 mutation-positive inoperable or metastatic melanoma, showed adverse events were […]
Amgen wins EU green light for first virus-based cancer drug
Approvals, Approvals, BRAF V600 Inhibitors, BRAF V600 inhibitors, Cancer Cells, EMA, FDA, FDA/Regulatory, Health, Herpes, Herpes Simplex Virus, Immune Response, Immunotherapies, Immunotherapy, M&A, M&A, MEK Inhibitors, MEK Inhibitors, Melanoma, New Drug ApprovalsA first-in-class drug from Amgen based on a tumor-killing virus was given a green light by European regulators on Friday, paving the way for its approval within a couple of months. The decision is a further milestone for a technology that has long fascinated scientists but has previously proved difficult to harness. The European […]