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APPROVED DRUGS The recommended dose of or mildly impaired renal function because for adjuvant treatment is 400 mg/day of the potential risk of subtherapeutic • (www.gene.com), a member administered with meals daily for three exposure to methotrexate. of the Roche Group, announced the years. The optimal duration of treatment Food and Drug Administration (FDA) has is not known. • Millennium: The Takeda Oncol- approved Erivedge™ () ogy Company (www.millennium.com) capsules for the treatment of adults • The FDA approved Inlyta ( announced that the FDA has approved with metastatic basal cell carcinoma tablets) (, Inc.www.pfizer. a supplemental new drug application (BCC) or with locally advanced BCC that com), a kinase inhibitor, for treatment for Velcade® (bortezomib), which has recurred following surgery or who are of patients with advanced renal cell updates the label to include the subcu- not candidates for surgery, and who are carcinoma (RCC) after failure of one prior taneous method of administration in all not candidates for radiation. systemic therapy. The approval is based approved indications: multiple myeloma Vismodegib inhibits the Hedge- on data from the Phase III AXIS trial, and mantel cell after at least hog pathway, an important embryonic which demonstrated that Inlyta signifi- one prior therapy. developmental pathway. Reproductive cantly extended progression free survival toxicology studies in rats demonstrated (PFS) [HR=0.67, 0.54-0.81, P<0.0001] that vismodegib exposure during organo- with a median PFS of 6.7 months (95% DRUGS IN THE NEWS genesis results in embryo-fetal death at CI: 6.3,8.6) compared with 4.7 months higher exposures and severe birth defects (95% CI: 4.6,5.6) for those treated with • Pinnacle Biologics, Inc. (www.pinnacle at exposures within the range achieved , a current standard of care for biologics.com) announced that the with the recommended human dose. this patient population. This improve- company has received orphan drug The recommended dose and schedule ment in PFS was greater in the cytokine- designation for Photofrin® (porfimer for vismodegib is 150 mg orally daily. pretreated subgroup compared to the sodium) as adjuvant therapy to surgery -pretreated subgroup. in treatment of malignant pleural • The FDA has granted regular approval mesothelioma. for Gleevec™ (imatinib mesylate • The FDA approved glucarpidase tablets) ( Pharmaceuticals, injection (Voraxaze®) (BTG Inter- • ZIOPHARM , Inc. (www. www.novartis.com) for the adjuvant national Ltd., www.btgplc.com) for the ziopharm.com) announced that the FDA treatment of adult patients following treatment of toxic plasma methotrexate has accepted its investigational new drug complete gross resection of Kit (CD117) concentrations (> 1μmol/L) in patients application (INDA) for the oral dos- positive gastrointestinal stromal tumors with delayed methotrexate clearance due ing of palifosfamide (Zymafos® or (GIST). Accelerated approval for this in- to impaired renal function. Glucarpidase ZIO-201). Palifosfamide is a novel DNA dication was granted in December 2008. is not indicated for use in patients cross-linker in class with bendamustine, Labeling is also revised to include the who exhibit the expected clearance of ifosfamide, and cyclophosphamide. results of a randomized trial demonstrat- methotrexate (plasma methotrexate ing that recurrence-free survival (RFS) concentrations within 2 standard devia- • Circadian Technologies Ltd. (www. and overall survival (OS) were improved tions of the mean methotrexate circadian.com.au) announced that the by continuing adjuvant imatinib therapy curve specific for the dose of methotrex- company’s wholly-owned subsidiary, to 36 months. ate administered) or those with normal Vegenics Pty Ltd., has received approval

18 OI | March–April 2012 | www.accc-.org EP Tracker Now Available Fulcrum Methods (www.fulcrummethods.com) announced release of EP Tracker™, a SaaS-based (software-as-a-service-based) interactive tool that helps centrally administer the lifelong process of individual EP registration and reporting and attestation. Hospitals, healthcare systems, and medical groups can use EP Tracker to ensure affiliated eligible professionals (EPs) have properly registered for and suc- cessfully completed requirements to qualify for meaningful use incentives. The tool tracks EP funds receipt by year and program, EP funds flow, and EP funds assign- ment. EP Tracker was developed and designed in conjunction with users of Fulcrum Methods’ Meaningful Use Assessment Tool.

for its INDA to initiate clinical trials of • The FDA has granted Royal Phillips • RaySearch Laboratories AB (www. VGX-100 in cancer patients with solid Electronics (www.healthcare.philips.com/ raysearchlabs.com) announced that ver- tumors. The first Phase I trial will study us_en/) 510(k) clearance for the com- sion 2.5 of the company’s RayStation® VGX-100 in patients with a variety of pany’s first commercially available whole treatment planning system has been late-stage . VGX-100 is a human body positron emission tomography/ released for clinical use in the U.S. and antibody that acts against the human magnetic resonance (PET/MR) imaging Europe. RayStation 2.5 includes all of VEGF-C protein. Treatment for cancers, system, the Ingenuity TF PET/MR. RaySearch’s optimization algorithms for particularly glioblastoma and metastatic VMAT, IMRT, and 3D-CRT along with a colorectal cancers, are the first target • MIM Software Inc. (www.mimsoftware. comprehensive set of tools for tradi- indications for VGX-100. com) announced that Mobile MIM™ has tional 3D-CRT planning. The new version received its second FDA 510(k) clearance includes improvements of RaySearch’s for release of its new version, Mobile unique multi-criteria optimization (MCO) DEVICES IN THE NEWS MIM 3.0. Mobile MIM is now cleared for solution for IMRT. diagnostic X-ray and ultrasound viewing, • Hologic, Inc. (www.hologic.com) an- as well as radiation treatment plan review • Veran Medical Technologies (www. nounced FDA approval of the company’s and approval. Mobile MIM 3.0 is available veranmedical.com) announced the Cervista HTA (high throughput on the Apple® App Store(SM). release of its SPiN Drive™ platform automation) System for use with Ho- upgrade for bi-planar virtual fluoros- logic’s previously approved human papil- • The FDA has granted Translational copy view used to navigate multiple lomavirus (HPV) HR test. The company’s Sciences Corporation (www.transcicorp. planes simultaneously. This advancement HPV HR test uses Hologic’s proprietary com) 510(k) clearance for commercial- enables physicians to view the location Invader technology to detect 14 high-risk ization of the company’s OncoTrac™ of the Always-On Tip Tracked™ instru- types of HPV that are associated with medical imaging software. ment in a fluoro-like view without any cervical cancer and precancerous lesions. OncoTrac is designed for efficient radiation being delivered to the patient, quantitative assessment of treatment physician, or staff. • Varian Medical Systems (www. response of metastatic tumors, includ- varian.com) announced updated control ing breast, lung, colorectal, prostate, • The FDA has granted Konica Minolta software, which received FDA 510(k) and lymphoma. OncoTrac products Medical Imaging USA (www.konicaminolta. clearance in November, that adds a provide a structured workflow solution com/medicalusa) 510(k) clearance for High Intensity Mode to the company’s for cancer practitioners and research- the company’s Xpress CR Digital Clinac® and Trilogy® machines, ers to report precise measurement of Mammography upgrade. The clear- enabling dose delivery rates of up to solid and metastatic tumors for routine ance specifically applies to the company’s 2400 monitor units per minute—double clinical care and cancer drug trials. As CP1M 18 x 24 and 24 x 30 cassettes their former highest output. Varian a vendor-neutral platform, OncoTrac and the use of the CS 3 control station also received FDA clearance for the software architecture is suitable for with the REGIUS 190 and 210 readers. Pivotal™ Care Solution Prone use in daily radiology practice, and can Breast Treatment, an innovation that be easily integrated into most existing allows patients to be treated on their PACS environments without any product stomachs rather than their backs. customization.

www.accc-cancer.org | March–April 2012 | OI 19