The number of electronic health record systems joining with CancerLinQ to facilitate information sharing continues to grow. CancerLinQ LLC, a wholly owned nonprofit subsidiary of the American Society of Clinical Oncology, announced Varian's ARIA Oncology Information System is the next Electronic Health Record System to be certified by CancerLinQ after meeting criteria for interoperability and data standardization. This collaboration aims to dismantle barriers to information sharing and streamline access to CancerLinQ for oncology practices using Varian ARIA OIS.
FDA is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in male patients.
FDA issued a warning letter to Inova Genomics Laboratory of Falls Church, Virginia, for illegally marketing certain genetic tests that have not been reviewed by the FDA for safety and effectiveness. The tests claim to predict patients' responses to specific medications based on genetic variants.
Nanobiotix announced Hensify (NBTXR3) has obtained a CE mark for the treatment of locally-advanced soft tissue sarcoma. Hensify is the brand name for NBTXR3 as approved for the treatment of locally-advanced STS.
Bristol-Myers Squibb Co. announced results from pooled analyses of survival data from four studies (CheckMate -017, -057, -063 and -003; n=664) in patients with previously-treated advanced non-small cell lung cancer who were treated with Opdivo (nivolumab).
Three completed cohorts reporting findings in non-small cell lung cancer, breast, and metastatic colorectal cancer from the American Society of Clinical Oncology Inc.'s Targeted Agent and Profiling Utilization Registry study were presented in poster sessions during the American Association for Cancer Research Annual Meeting 2019.
FDA announced steps to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care.
FDA is alerting health care professionals, oncology clinical investigators and patients about the risks associated with the investigational use of Venclexta (venetoclax) for the treatment of patients with multiple myeloma based on data from a clinical trial. Venclexta is not approved for the treatment of multiple myeloma.
The Janssen Pharmaceutical Co. has submitted a supplemental Biologics License Application to FDA seeking approval of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant.
Breath Diagnostics Inc. and Mayo Clinic Laboratories announced a collaboration to develop clinical diagnostic tests that use patient breath samples to identify individual biomarkers that can predict a spectrum of diseases. The two organizations will initially focus on a test that can detect lung cancer.