Zejula Gets Priority Review for Late Stage Ovarian Cancer Indication
The sNDA is supported by data from the multicenter phase 2 QUADRA trial that evaluated the safety and activity of Zejula in 463 patients.
All articles by Brian Park, PharmD
FDA Approves Novel Therapy for Relapsed, Refractory Multiple Myeloma
Continued approval of Xpovio for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Phase 3 Study Evaluating Novel Therapy for Pancreatic Cancer Discontinued
Boston Biomedical has announced that the CanStem111P study investigating napabucasin in patients with metastatic pancreatic cancer will be discontinued due to futility.
Fluorouracil Injection Recalled Due to Glass Particulate
No reports of adverse events have been received at this time, as per the Company.
Revlimid Plus Rituximab Approved for Follicular Lymphoma, Marginal Zone Lymphoma
The FDA has approved Revlimid (lenalidomide; Celgene) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma or marginal zone lymphoma.
Mirvetuximab Soravtansine Data Lacking for FDA’s Accelerated Approval in Ovarian CA
Mirvetuximab soravtansine is the first folate receptor alpha-targeting antibody-drug conjugate.
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