FDA granted Priority Review to venetoclax for the treatment of chronic lymphocytic leukemia in adults who have received at least one prior therapy, including patients with 17p deletion.
AMY MCKEE was appointed acting deputy office director in the FDA Office of Hematology Oncology Products.
A phase III study of the Delcath Hepatic Delivery System (Melphalan/HDS) for the treatment of melanoma patients with liver metastases, met its primary endpoint of hepatic progression-free survival.
A phase III study of Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, demonstrated improvements in median overall survival in post-gemcitabine metastatic pancreatic cancer patients.
FDA approved Opdivo (nivolumab) injection for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.
Adult patients under 60 years of age with newly-diagnosed FLT3-mutated acute myeloid leukemia who received the investigational compound PKC412 (midostaurin), plus standard induction and consolidation chemotherapy, experienced a 23 percent improvement in overall survival (HR=0.77, p=0.0074), compared to those treated with standard induction and consolidation chemotherapy alone.
Results from the phase III head-to-head ENDEAVOR study comparing Kyprolis to Velcade in patients with relapsed multiple myeloma showed that patients treated with Kyprolis achieved progression-free survival of 18.7 months compared to 9.4 months (HR=0.53; 95% CI: 0.44, 0.65; p<0.0001).
Amgen submitted a variation to its Kyprolis marketing authorization application to the European Union, to include a combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The application is based on results from the phase III head-to-head ENDEAVOR study in which patients with multiple... […]
The European Medicines Agency granted Orphan Drug Designation to Debio 1143 for treatment of ovarian cancer. Debio 1143 is an oral, small molecule inhibitor of apoptosis proteins with a dual pro-apoptotic and immunomodulatory mode of action developed as a potent chemo/radiosensitizer in oncology. Further to the encouraging signs of efficacy seen in clinical phase I... […]
FDA cleared for marketing the first cooling cap to reduce hair loss in female breast cancer patients undergoing chemotherapy. The Dignitana DigniCap Cooling System is indicated to reduce the frequency and severity of alopecia during chemotherapy in breast cancer patients in which alopecia-inducing chemotherapeutic agents and doses are used. It is a computer-controlled system that... […]
