FDA Grants Accelerated Approval to Brukinsa for Mantle Cell Lymphoma
Continued approval may be contingent upon verification of clinical benefit in a confirmatory trial.
Continued approval may be contingent upon verification of clinical benefit in a confirmatory trial.
The FDA has approved Ziextenzo (pegfilgrastim-bmez; Sandoz), a biosimilar to Neulasta.
Halozyme Therapeutics announced that the phase 3 HALO-301 study of PEGPH20 as a first-line therapy for treatment of patients with metastatic pancreatic cancer has failed to meet the primary end point of overall survival.
Zejula, a poly(ADP-ribose) polymerase (PARP) inhibitor, is also approved for maintenance treatment in adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Study authors suggest a more complete analysis of the lung’s response to BCG vaccination needs to be conducted in human trials.
Erleada plus ADT achieved statistical significance in meeting both primary end points of OS and rPFS in the phase 3 TITAN study.
Healthcare professionals are being advised to monitor patients regularly for pulmonary symptoms indicative of ILD and/or pneumonitis, including hypoxia, cough, dyspnea, and interstitial infiltrates on radiologic exams.
AbbVie has announced that the research and development program for its investigational drug, Rova-T will be terminated based on a lack of survival benefit in the phase 3 MERU trial.
The FDA clarified that the risk of cancer associated with exposure to nitrosamine impurities was likely lower than what was initially assessed.
The FDA has approved Inrebic (fedratinib; Celgene) capsules to treat adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.