Drugs & Targets

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.

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.

The European Medicines Agency granted an orphan drug designation to ImMucin for the treatment of multiple myeloma. ImMucin targets the less studied signal peptide domain of the MUC1 tumor antigen.