Genentech announced the randomized phase III CLL14 study, which evaluated fixed-duration Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia and co-existing medical conditions, met its primary endpoint and showed a statistically significant reduction in the risk of disease worsening or death (progression-free survival as assessed by investigator) compared to standard-of-care Gazyva plus chlorambucil.
TESARO Inc. announced the achievement of development milestones that trigger an $18 million payment from Janssen Biotech Inc.
Cofactor Genomics has launched an RNA-based immune profiling kit developed for laboratories wishing to derive the immune composition of tumor samples.
Taiho Oncology Inc. said FDA has accepted and granted priority review for the supplemental New Drug Application for Lonsurf (trifluridine/tipiracil, TAS-102) for previously treated, advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction.
Bristol-Myers Squibb Co. announced updates regarding regulatory actions by health authorities in the U.S. and European Union for the ongoing review of its applications for an indication in metastatic first-line non-small cell lung cancer with Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) in patients with tumor mutational burden ≥10 mutations/megabase.
Zai Lab Limited, a Shanghai-based biopharmaceutical company, announced the Hong Kong Department of Health has approved Zejula (niraparib), an oral, once-daily poly polymerase inhibitor in Hong Kong for adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian cancer who are in a complete response or partial response to platinum-based chemotherapy.
The National Comprehensive Cancer Network Oncology Research Program announces plans to develop a program to scientifically evaluate and facilitate clinical trials on the efficacy of trifluridine and tipiracil chemotherapy.
FDA has approved BRACAnalysis CDx to be used by healthcare professionals to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are eligible for treatment with Pfizer's PARP inhibitor, Talzenna (talazoparib).
FDA announced the availability of the draft guidance titled “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biologic Products for Treatment.”
Some European countries take more than twice as long as others to reach health technology assessment decisions to reimburse new cancer drugs following their approval by the European Medicines Agency.
