FDA approved Epclusa to treat adult patients with chronic hepatitis C virus both with and without cirrhosis. For patients with moderate to severe cirrhosis, Epclusa is approved for use in combination with the drug ribavirin.
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. For further information, contact the principal investigator listed.
A phase III study evaluating Gazyva (obinutuzumab) plus CHOP chemotherapy in people with previously untreated diffuse large B-cell lymphoma did not meet its primary endpoint of progression-free survival compared to Rituxan (rituximab) plus CHOP chemotherapy, according to Genentech, a member of the Roche Group.
A phase III study evaluating Gazyva (obinutuzumab) plus CHOP chemotherapy in people with previously untreated diffuse large B-cell lymphoma did not meet its primary endpoint of progression-free survival compared to Rituxan (rituximab) plus CHOP chemotherapy, according to Genentech, a member of the Roche Group.
Results from a phase III trial of patients with metastatic colorectal cancer demonstrated that Erbitux (cetuximab) plus FOLFOX improved outcomes—including progression-free survival, overall survival and best overall response rate—when compared with FOLFOX alone.
Positive results from a phase III trial in advanced colorectal cancer showed that Xilonix-treated patients with advanced disease and multiple symptoms known to inversely correlate with overall survival experienced a 76 percent relative increase in clinical response rate after eight weeks of therapy compared to placebo, at 33 percent vs. 19 percent, respectively (p=.0045).
Amgen and Allergan plc announced results from a phase III study evaluating efficacy and safety of biosimilar ABP 980 compared with trastuzumab in patients with human epidermal growth factor receptor 2-positive early breast cancer.
Niraparib achieved its primary endpoint in a phase III ovarian cancer trial, demonstrating prolonged progression-free survival compared to placebo among patients who are germline BRCA mutation carriers; among patients who are not germline BRCA mutation carriers, but who have homologous recombination deficient tumors as determined by the Myriad myChoice HRD test; and overall in patients who are not germline BRCA mutation carriers.
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. For further information, contact the principal investigator listed.
A secondary analysis of the phase III ASPIRE trial that showed Kyprolis (carfilzomib) for Injection, in combination with lenalidomide and dexamethasone, improved progression-free survival and overall response rate, compared to lenalidomide and dexamethasone alone, in patients with relapsed multiple myeloma with early disease progression after initial therapy or transplant.