FDA granted Priority Review for defibrotide for the treatment of patients with hepatic veno-occlusive disease, also known as sinusoidal obstruction syndrome, with evidence of multi-organ dysfunction following hematopoietic stem-cell transplantation. FDA review of the new drug application is expected to be completed by March 31, 2016. The application, submitted by Jazz Pharmaceuticals plc, includes safety... […]
FDA approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. The agency previously granted Priority Review and orphan drug designations for Onivyde. The effectiveness of Onivyde was demonstrated in a phase III, three-arm, randomized, open label study of... […]
FDA approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting.
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. For further information, contact the principal investigator listed.
Telotristat etiprate showed clinical benefit in treating carcinoid syndrome in cancer patients not adequately controlled by long-acting somatostatin analog therapy, the current standard of care, according to data from the phase III TELESTAR study.
A phase II study of Cyramza (ramucirumab) in combination with docetaxel met its primary endpoint, demonstrating a statistically significant increase in progression-free survival for patients with locally advanced or metastatic urothelial carcinoma who failed prior platinum-based therapy.
Two separate papers published in the New England Journal of Medicine showed that imetelstat demonstrated disease-modifying activities in phase II studies of myelofibrosis and essential thrombocythemia.
OncoGenex Pharmaceuticals Inc. presented results from additional exploratory analyses of the phase III SYNERGY trial, demonstrating that custirsen treatment significantly lowered serum clusterin levels from baseline in men with metastatic castrate-resistant prostate cancer.
Novartis announced results of a phase III study showing Afinitor (everolimus) tablets reduced the risk of progression by 52 percent (HR=0.48; 95% CI, 0.35-0.67; p<0.00001) compared to placebo in patients with advanced, progressive, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin.
Amgen and Allergan plc. announced positive top-line results from Avastin biosimilar candidate ABP 215, which met its primary and secondary endpoints in a phase III trial in advanced non-squamous non-small cell lung cancer.
