FDA granted Rintega (rindopepimut) a Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma.
FDA granted accelerated approval to Ibrance (palbociclib) to treat metastatic breast cancer.
FDA approved Lenvima (lenvatinib) for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. Lenvima was approved following a priority review.
The U.K. National Health Service established an access program for the Oncotype DX test, developed by Genomic Health Inc., for breast cancer patients, effective April 1.
FDA granted an Orphan Drug Designation to Reolysin for the treatment of pancreatic cancer.
FDA granted an Orphan Drug Designation to antinuclear antibody conjugated liposomal doxorubicin, developed by NanoSmart Pharmaceuticals Inc., for the treatment of Ewing's sarcoma, a rare cancer that develops in or around children's bones.
FDA granted an Orphan Drug Designation to Saposin C, the active ingredient in drug BXQ-350, for the potential treatment of glioblastoma multiforme.
FDA expanded the existing indication for Revlimid (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma.
The European Commission approved a variation to the terms of the marketing authorization of Velcade (bortezomib), in combination with rituximab, cyclophosphamide, doxorubicin and prednisone, for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for blood stem-cell transplantation.
The FDA Oncologic Drugs Advisory Committee and the Cellular, Tissue and Gene Therapies Advisory Committee will jointly review talimogene laherparepvec for the treatment of patients with injectable regionally or distantly metastatic melanoma at a meeting April 29.
