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.
The Food and Drug Administration (FDA) has granted accelerated approval to Rozlytrek (entrectinib; Genentech).
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to bempegaldesleukin (NKTR-214; Nektar Therapeutics and Bristol-Myers Squibb) in combination with nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of patients with previously untreated unresectable or metastatic melanoma.
The Breakthrough Therapy designation was based on updated interim results from the multicenter, open-label, phase 1b KEYNOTE-524/Study 116 trial.
Imfinzi is a programmed death-ligand (PD-L1) blocking antibody.
The sNDA is supported by data from the multicenter phase 2 QUADRA trial that evaluated the safety and activity of Zejula in 463 patients.
Continued approval of Xpovio for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Boston Biomedical has announced that the CanStem111P study investigating napabucasin in patients with metastatic pancreatic cancer will be discontinued due to futility.
