FDA granted regular approval to the combination of rituximab and hyaluronidase human (Rituxan Hycela) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.
FDA granted regular approvals to dabrafenib and trametinib (Tafinlar and Mekinist) administered in combination for patients with metastatic non-small cell lung cancer with BRAF V600E mutation as detected by an FDA-approved test.
FDA granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing-based test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non-small cell lung cancer.
FDA rejected Pfizer's Biologics License Application for its proposed epoetin alfa biosimilar to Amgen's Epogen, citing significant violations of good manufacturing practice regulations for finished pharmaceuticals at the company's drug manufacturing facility, Hospira Inc., in McPherson, KS.
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).
