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Approved Drugs • The FDA has approved a new indication Approved Devices for Vectibix® (panitumumab) (Amgen, • The Food and Drug Administration (FDA) www.amgen.com) for use in combination • Olympus (www.medical.olympusamerica. has approved Aloxi® (palonosetron HCI) with FOLFOX, as first-line treatment in com) announced the commercial availability injection (Eisai Inc., www.eisai.com/US) for patients with wild-type KRAS metastatic of its 510(k) cleared, next-generation the prevention of acute nausea and colorectal cancer (mCRC). The FDA also Endocapsule 10 System for small bowel vomiting associated with initial and repeat approved the Therascreen® KRAS RGQ capsule endoscopy procedures; BF-P190 courses of emetogenic cancer chemother- PCR Kit (Qiagen, www.qiagen.com) as a and BF-XP190 bronchoscopes for apy, including highly emetogenic cancer companion diagnostic for Vectibix. Vectibix peripheral and small anatomy bronchos- chemotherapy, in children aged 1 month is not indicated for the treatment of copy; and GIF-1TH190 gastrointestinal to less than 17 years. patients with KRAS-mutant mCRC or for videoscope for endoscopy or endoscopic whom KRAS mutation status is unknown. surgery use within the upper digestive tract. • Eli Lilly and Company (www.lilly.com) announced that the FDA has approved • Novartis (www.novartisoncology.com) • GE Healthcare (www.gehealthcare.com) Cyramza™ (ramucirumab) for use as a announced FDA approval of Zykadia™ announced FDA approval and the U.S. single agent for the treatment of patients (certinib) for patients with a certain type launch of their new breast imaging with advanced or metastatic, gastric or of late-stage non-small cell lung cancer. technology, the Invenia™ ABUS. gastroesophageal junction (GEJ) adenocarci- noma with disease progression on or after Drugs in the News Generic Version of Paraplatin® prior treatment with fluoropyrimidine- or Injection Launched platinum-containing chemotherapy. • The FDA has granted orphan drug Mylan Inc. (www.mylan.com) has designation to ADXS-HPV (Advaxis, Inc., launched Carboplatin Injection, • The FDA has approved a 20 mg/ml oral www.advaxis.com) for the treatment of 50 mg/5 ml, in multi-dose vials, ™ suspension of Purixan (mercaptopurine) Stage II-IV invasive cervical cancer. ADXS- a generic version of Bristol-Myers (NOVA Laboratories Limited, www.novalabs. HPV is an immunotherapy that is designed Squibb’s Paraplatin Injection. co.uk). Purixan is indicated for the treatment to target cells expressing the HPV gene E7. of patients with acute lymphoblastic leukemia as part of a combination regimen. • OncoMed Pharmaceuticals Inc., Genetic Testing Registry (www.oncomed.com) announced that In response to continued advances • Teva Pharmaceutical Industries Ltd. Demcizumab (anti-DLL4, OMP-21M18) in genomic technology and genetic (www.tevapharm.com) announced that the has received FDA orphan drug designation medicine, the National Institutes of FDA has approved Synribo® (omacetax- for the treatment of pancreatic cancer. Health has developed the Genetic ine mepesuccinate) for injection, for Testing Registry, a free online subcutaneous use, to include home • The FDA has granted orphan drug resource, to provide physicians, administration; the agency also approved designation to Selinexor (KPT-330) oral researchers, and patients with a related Medication Guide and Instruc- (Karyopharm Therapeutics Inc., www. detailed and accurate information tions for Use. karyopharm.com) for the treatment of about genetic and genomic tests. acute myeloid leukemia. www.ncbi.nlm.nih.gov/gtr.
18 www.accc-cancer.org | July–August 2014 | OI