sign in sign up
<<
Home , Ibrutinib

tools

Approved Drugs date of August 9, 2014. Spectrum is seeking enables intensity-modulated proton therapy approval of Beleodaq for the treatment of (IMPT) by modulating dose levels on a • , Inc. (www.janssen patients with relapsed or refractory peripheral spot-by-spot basis throughout the biotech.com) announced that the Food and T-cell (R/R PTCL). treatment area. Irradiations from multiple Drug Administration (FDA) expanded the angles are combined in an optimal manner approved use of Imbruvica (ibrutinib) for • The FDA has granted orphan drug to improve control of dose distributions. chronic lymphocytic (CLL) patients designation to BL-8040 (BioLineRx, www. Scanning beam technology also eliminates who have received at least one previous biolinerx.com) as a treatment for stem-cell the time-consuming need to manually therapy. Imbruvica works by blocking the mobilization. The orphan drug designation insert separate shaping accessories for each enzyme that allows cancer cells to grow and was granted for use of BL-8040, in combina- beam angle in order to match the beam to divide. In November 2013, the FDA granted tion with granulocyte colony-stimulating the shape of the tumor. Imbruvica accelerated approval to treat factor (G-CSF), to mobilize human stem cells patients with , a rare from the bone marrow to the peripheral • IMRIS Inc. (www.imris.com) announced it and aggressive type of blood cancer, if those blood for collection for autologous or has received FDA clearance for the newest patients received at least one prior therapy. allogeneic (donor-based) transplantation. It generation VISIUS® Surgical Theatre, is in addition to the orphan drug designa- which integrates Siemens’ latest high-field • The FDA has approved GlaxoSmithKline’s tion previously granted to BL-8040 as a MRI scanners. The new core imaging (www.gsk.com) Mekinist® (trametinib) treatment for acute myeloid leukemia (AML). technology based on Siemens Aera 1.5T for use in combination with Tafinlar® (tesla) and Skyra 3.0T technology helps () for the treatment of patients Approved Devices IMRIS deliver better image quality with with unresectable melanoma or metastatic higher signal-to-noise ratio, faster 3D image melanoma with BRAF V600E or V600K • Miltenyi Biotec (www.miltenyibiotic.com) acquisition, and improved ease-of-use and mutations. These mutations must be announced that the FDA has approved the workflow during neurosurgical procedures detected by an FDA-approved test. Tafinlar is company’s CliniMACS CD34 Reagent using intraoperative MRI. not indicated for treatment of patients with System as a humanitarian use device for wild-type BRAF melanoma. The FDA the prevention of graft-versus-host disease Genetic Tests and Assays approved the combination of Mekinist and (GVHD) in patients with AML in first in the News Tafinlar under the agency’s accelerated complete remission undergoing allogeneic approval program. stem cell transplantation (SCT) from a • Ventana HER2/neu (4B5) Rabbit matched related donor. The FDA approval Monoclonal Primary Antibody Assay Drugs in the News was based on data from a Phase II, (Ventana Medical Systems, Inc., http:// single-arm, multi-center study (BMT CTN ventana.com) can be used as a companion • Spectrum Pharmaceuticals (www.sppirx. 0303) conducted by the Blood and Marrow diagnostic for detecting HER2 protein com) announced that its new drug applica- Transplant Clinical Trials Network. expression for patients who, in countries tion (NDA) for Beleodaq, a novel pan-histone where they are approved, may be appropri- deacetylase (HDAC) inhibitor, has been • ProBeam™ proton therapy system ate candidates for Perjeta® () accepted for filing by the FDA and granted (Varian Medical Systems, www.varian.com) and Kadcycla™ (ado-trastuzumab priority review. The FDA has assigned a has received FDA 510 (k) clearance. The emtansine). User Fee Act (PDUFA) action system’s scanning beam technology

OI | March–April 2014 | www.accc-cancer.org 17