FDA approved Jadenu (deferasirox) tablets, a new oral formulation of Exjade (deferasirox) tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes in patients 10 years of age and older.
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.
FDA granted Priority Review to Kyprolis (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The agency also accepted the drug's supplemental new drug application designed to support the conversion of accelerated approval to full approval and expand the current Kyprolis indication. FDA set a target action date of July 26.
FDA granted accelerated approval to Farydak (panobinostat) for the treatment of patients with multiple myeloma.
Rich Pharmaceuticals Inc. published a letter of intent with Khon Kaen University in Thailand to conduct clinical trials using Rich's molecule therapy RP-323 in treating AML patients.
The European Medicines Agency granted Orphan Drug Designation to Reolysin, for the treatment of ovarian, fallopian tube and primary peritoneal cancers.
The European Committee for Medicinal Products for Human Use granted a positive opinion for Gardasil 9, the first nine-valent HPV vaccine.
Teikoku Pharma USA submitted a New Drug Application to FDA for Docetaxel Injection Concentrate, Non-Alcohol Formula, for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.
The European Commission approved Jakavi (ruxolitinib) for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients.
The Hong Kong Department of Health approved Abraxane (albumin-bound paclitaxel) for use in combination with gemcitabine as first-line treatment for patients with late-stage pancreatic cancer.
