Senhwa Biosciences Inc. of Taipei and San Diego received the orphan drug designation to CX-4945 for the treatment of cholangiocarcinoma.
The American Joint Committee on Cancer has incorporated the Oncotype DX test in its recently published Eighth Edition AJCC Cancer Staging Manual.
FDA granted an accelerated approval to rucaparib (Rubraca) for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies.
MERCK announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending approval of Keytruda (pembrolizumab) for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) with no EGFR or ALK positive tumor mutations.
VERASTEM INC. and Infinity Pharmaceuticals Inc. entered into a license agreement under which Verastem licensed exclusive worldwide rights to develop and commercialize Infinity’s oncology product candidate duvelisib. Duvelisib is an investigational, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes that are known to help support the growth and survival of malignant B cells... […]
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... […]
