FDA approved betrixaban (BEVYXXA) for the prophylaxis of venous thromboembolism in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.
Amgen said FDA has accepted the Xgeva (denosumab) supplemental Biologics License Application that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.
FDA approved the immunotherapy Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
FDA approved aminolevulinic acid hydrochloride, known as ALA HCl, as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery.
OncoSec Medical Inc. said FDA has granted the orphan drug designation for pIL-12, otherwise known as tavokinogene telsaplasmid, for the treatment of unresectable metastatic melanoma. Tavokinogene telsaplasmid is the active biologic agent in OncoSec's lead product candidate, ImmunoPulse IL-12.
Bristol-Myers Squibb and Novartis announced a clinical research collaboration to investigate the safety, tolerability, and efficacy of Mekinist (trametinib) in combination with Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a potential treatment option for metastatic colorectal cancer in patients with microsatellite stable tumors where the tumors are proficient in mismatch repair (MSS mCRC pMMR).
FDA approved the Ventana ALK CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer patients eligible for treatment with the Novartis drug Zykadia (ceritinib).
Hologic Inc. said the Genius 3D Mammography exam has become the only mammogram that is FDA-approved as superior to standard 2D mammography for routine breast cancer screening of women with dense breasts.
Amgen and Allergan said the FDA Oncologic Drugs Advisory Committee will review data supporting the Biologics License Application for ABP 215, a biosimilar candidate to Avastin (bevacizumab), an agent sponsored by Genentech, a unit of Roche.
Hitachi Healthcare Americas Corp. and MD Anderson Cancer Center announced an agreement to collaborate on a randomized clinical trial comparing the outcomes and side-effects of intensity-modulated proton beam therapy versus intensity-modulated photon therapy for the treatment of oropharyngeal cancer of the head and neck.
