Janssen Biotech said FDA approved Nov. 21 daratumumab (Darzalex) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Merck announced that the phase III KEYNOTE-045 trial investigating the use of Keytruda (pembrolizumab), the company's anti-PD-1 therapy, in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival.
Array BioPharma and Pierre Fabre announced new results from the pivotal phase III COLUMBUS trial of binimetinib plus encorafenib (bini/enco) treatment in BRAF-mutant melanoma patients at the Society for Melanoma Research Annual Congress.
GENENTECH, a member of the Roche Group, received a second Breakthrough Therapy Designation from FDA for its anaplastic lymphoma kinase inhibitor, Alecensa (alectinib). The latest BTD was granted for the treatment of adult patients with advanced ALK-positive non-small cell lung cancer who have not received prior treatment with an ALK 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.
Revamping front-line multi-drug chemotherapy for retinoblastoma to include topotecan helped to maintain high cure rates for the eye cancer while preserving patients' vision and reducing their risk of treatment-related leukemia. Results of the St. Jude Children's Research Hospital study appear online today in the Journal of Clinical Oncology.
Amgen announced top-line results of the phase III CLARION trial, which evaluated an investigational regimen of Kyprolis (carfilzomib), melphalan and prednisone (KMP) versus Velcade() (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant.
Merrimack Pharmaceuticals Inc. announced final results from the pivotal phase III NAPOLI-1 study validating the use of ONIVYDE (irinotecan liposome injection) in combination with fluorouracil (5-FU) and leucovorin, which represents a new standard of care for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) following treatment with gemcitabine-based therapy.
Results from the pivotal phase III MONALEESA-2 study show LEE011 (ribociclib) plus letrozole significantly extended progression-free survival (PFS), compared to a standard of care, letrozole, as a first-line treatment in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (median PFS, 95% CI (19.3 months - not reached) vs 14.7 months (13.0 - 16.5 months); HR=0.556; p=0.00000329.
A retrospective analysis of the PEAK study in mCRC patients with RAS wild-type primary tumors of left-sided origin showed that patients receiving Vectibix plus FOLFOX6 as first-line treatment achieved 43.4 months median overall survival (OS), an increase of 11.4 months when compared to FOLFOX6 plus bevacizumab.
