FDA approved a label update for Zytiga (abiraterone acetate) plus prednisone to include overall survival results in chemotherapy-naive men with metastatic castration-resistant prostate cancer.
Astellas Pharma Inc. and Medivation Inc. presented an updated overall survival analysis from the placebo-controlled phase III trial of Xtandi in chemotherapy-naive metastatic CRPC.
A phase III study investigating Keytruda patients with advanced melanoma met two primary endpoints, demonstrating improvements in progression-free survival and overall survival compared to Yervoy. The study's independent data monitoring committee recommended stopping the trial early.
A phase II study of pacritinib in patients with myelofibrosis demonstrated that pacritinib is active in patients with myelofibrosis, resulting in spleen volume reduction, while producing substantial and prolonged improvement in disease-related symptoms without causing clinically significant myelosuppression.
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. For further information, contact the principal investigator listed. Phase I 9676: A Phase 1 Trial of MK-3475 Plus Ziv- Aflibercept in Patients with Advanced Solid Tumors. Dana-Farber Harvard Cancer Center; Hodi, Frank Stephen. (617) 632-5053 ABTC-1401: Phase 1 Dose... […]
Clinical-trial findings suggested that combining chemotherapy with radiation therapy is the best treatment for people with a low-grade form of brain cancer.
A phase III trial of Halaven (eribulin) in patients with soft tissue sarcoma demonstrated a statistically significant extension in overall survival over the comparator treatment dacarbazine, the primary endpoint of the study. No other systemic treatment for locally advanced or metastatic soft tissue sarcoma has been reported to extend overall survival in a phase III study, according to Halaven's sponsor, Eisai.
FDA granted accelerated approval to Farydak (panobinostat) for the treatment of patients with multiple myeloma.
Preliminary results from the phase II STAND trial showed a robust immune response with Provenge (sipuleucel-T) that continued two years after completing treatment in men with biochemically-recurrent prostate cancer.
An independent data monitoring committee recommended unblinding the phase III HELIOS trial, which is evaluating Imbruvica in combination with bendamustine and rituximab in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, following clinically meaningful and statistically significant treatment benefit.
