FDA approved Opdivo (nivolumab) injection for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.
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 II study of CPX-351 in adult patients with first-relapse acute myeloid leukemia demonstrated clinical benefit in patients with poor-risk disease as defined by the European Prognostic Index.
Top-line results of the phase III MARIANNE study evaluated three HER2-targeted regimens—Kadcyla (ado-trastuzumab emtansine) plus Perjeta (pertuzumab), Kadcyla alone, and Herceptin (trastuzumab) plus taxane chemotherapy—in people with previously untreated advanced HER2-positive breast cancer.
Amgen presented data from the phase II PEAK and phase III PRIME studies evaluating first-line use of Vectibix (panitumumab) in combination with FOLFOX chemotherapy regimen in patients with wild-type RAS metastatic colorectal cancer.
Two independent phase III clinical trials, LUX-Lung 3 and LUX-Lung 6, in epidermal growth factor receptor mutation-positive metastatic non-small cell lung cancer demonstrated positive results in overall survival.
A phase III clinical trial demonstrated Jakavi (ruxolitinib) significantly improved hematocrit control without the need for phlebotomy and reduced spleen size in patients with polycythemia vera who had an inadequate response to or unacceptable side effects from hydroxyurea, as defined according to the modified European LeukemiaNet criteria.
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. For further information, contact the principal investigator listed.
Amgen ended all of its clinical studies of rilotumumab in advanced gastric cancer, including the phase III RILOMET-1 and RILOMET-2 trials.
A phase II trial of Imbruvica showed that more than 30 percent of treated relapsed/refractory mantle cell lymphoma patients remained progression-free after two years with no new or unexpected adverse events occurring during that time. Forty-seven percent of the 111 patients treated were still living at the 27-month median follow-up.
