AVASTIN (bevacizumab) received FDA approval to be used either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
ATHENEX Inc. and Eli Lilly and Co. are collaborating on a study to evaluate the safety and tolerability of oraxol, an oral form of paclitaxel, in combination with Cyramza (ramucirumab), a vascular endothelial growth factor Receptor 2 antagonist, in patients with advanced gastric (stomach) and esophageal cancer. Patient enrollment, expected to start next year, is... […]
ICLUSIG (ponatinib) received full FDA approval for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia for whom no other tyrosine kinase inhibitor) therapy is indicated; and for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast... […]
QVCAD, a next generation CAD system for automated breast ultrasound, also known as “ABUS,” based on deep learning algorithms, has received FDA approval. Unlike existing CAD systems, which are used as a second read, QVCAD is the first FDA PMA-approved CAD system for concurrent reading. QVCAD presents the CAD results, including a C-thru Navigator image... […]
BRISTOL-MYERS SQUIBB and Enterome SA entered into an immuno-oncology focused collaboration agreement for the discovery and development of microbiome-derived biomarkers, drug targets and bioactive molecules to be developed as potential companion diagnostics and therapeutics for cancer. The collaboration will combine Bristol-Myers Squibb’s expertise in the discovery and development of novel immunotherapies with Enterome’s proprietary metagenomic... […]
AVELUMAB was accepted for Priority Review by FDA. The drug is sponsored by Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono. The drug is being developed through an alliance between Merck KGaA and and Pfizer Inc. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer’s PD-1... […]
DARZALEX received FDA approval 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.
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.
AMGEN and ALLERGAN plc. have submitted a Biologics License Application to FDA for ABP 215, a biosimilar candidate to Avastin (bevacizumab). ABP 215 is the most advanced of the four oncology biosimilar medicines that Amgen and Allergan are collaborating on. The companies said they believe this submission is the first bevacizumab biosimilar application submitted to FDA.
NAPABUCASIN received the Orphan Drug Designation from FDA in the treatment of pancreatic cancer. This is the second Orphan Drug Designation for napabucasin, an orally administered agent designed to inhibit cancer stemness pathways by targeting STAT3; the first designation was for gastric cancer including gastroesophageal junction cancer. Napabucasin, which is being developed by Boston Biomedical,... […]
