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Approved Drugs two other indications: treatment of Hodgkin glioma. Ad-RTS-hIL-12 is a novel gene therapy lymphoma patients who fail autologous candidate for the controlled expression of • Seattle Genetics, Inc. (www.seattlegenet- transplant or who fail at least two prior IL-12, a critical protein for stimulating an ics.com) announced that the Food and Drug multi-agent chemotherapy regimens and anti-cancer T cell immune response. Administration (FDA) has approved are not autologous transplant candidates, Adcetris® (brentuximab vedotin) for the and treatment of systemic ALCL patients • The FDA has granted orphan drug treatment of patients with classical Hodgkin who fail at least one prior multi-agent designation to Novogen Limited lymphoma at high risk of relapse or chemotherapy regimen. (www.novogen.com) for its chemotherapy progression as post-autologous hematopoi- candidate drug, Anisina (ATM-3507). etic stem cell transplantation consolidation. • FDA has approved AstraZeneca’s (www. The drug is for neuroblastoma. Adcetris is an antibody-drug conjugate astrazeneca.com) drug Iressa® (gefitinib) directed to CD30, which is expressed in for the treatment of patients with meta- • ASLAN Pharmaceuticals (www.aslan- classical HL and systemic anaplastic large static non-small cell lung cancer (NSCLC) pharma.com) announced that the FDA has cell lymphoma (ALCL), as well as other whose tumors have epidermal growth factor granted orphan drug designation to its lymphoma subtypes. This is the third receptor (EGFR) exon 19 deletions or exon 21 pan-HER inhibitor Varlitinib (ASLAN001) for indication for the drug, which was granted (L858R) substitution mutations as detected cholangiocarcinoma, a rare and very accelerated FDA approval in August 2011 for by an FDA-approved test. This approval of aggressive form of bile duct cancer. gefitinib is being approved concurrently with a labeling expansion of the theracreen® EGFR • Cleave Biosciences (www.cleavebio.com) RGQ PCR Kit, a companion diagnostic test announced that its lead drug candidate, CMS Expands Medicare Anti- for patient selection. CB-5083, has been granted orphan drug Cancer Treatment Compendia List designation by the FDA for the treatment of On Aug. 12, 2015, the Centers for • Odomzo® capsules (sonidegib), multiple myeloma. CB-5083 is an oral Medicare & Medicaid Services (CMS) Novartis Pharmaceuticals Corporation, inhibitor of p97, a critical enzyme that issued a decision adding Wolters (www.us.novartis.com), has received FDA controls various aspects of protein homeo- Kluwer Lexi-Drugs® to the list of approval for the treatment of patients with stasis. Cleave is currently evaluating CB-5083 compendia in Chapter 15, section locally advanced basal cell carcinoma (BCC) in two Phase I studies, including one in 50.4.5 of the Medicare Benefit Policy that has recurred following surgery or patients with multiple myeloma, and one in Manual, for use in the determination radiation therapy, or those who are not patients with solid tumor malignancies. of a “medically-accepted indication” candidates for surgery or radiation therapy. of drugs and biologicals used • The FDA has granted NanoSmart off-label in an anticancer chemother- Pharmaceutical (www.nanosmartpharma. apeutic regimen, unless the Secretary Drugs in the News com) orphan drug designation for a second has determined that the use is not drug product that uses NanoSmart’s medically appropriate or the use is • ZIOPHARM Oncology, Inc. (www. proprietary drug delivery platform. The drug identified as not indicated in one or ziopharm.com) announced that the FDA product is a formulation of dactinomycin more such compendia. has granted orphan drug designation for for the treatment of Ewing’s sarcoma. Ad-RTS-hIL-12 + veledimex in the treatment of patients with malignant

20 www.accc-cancer.org | September–October 2015 | OI • The FDA has granted PNP Therapeutics for the treatment of patients with relapsed • The Ventana ALK (D5F3) CDx Assay (www.pnptherapeutics.com) orphan drug multiple myeloma as a monotherapy. (Ventana Medical Systems, Inc., www. status for Gedeptin™ (adenoviral vector ventana.roche.com) has received FDA expressing E. coli purine nucleoside • The FDA has granted breatkthrough approval as a companion diagnostic to aid phosphorylase gene) for the intratumoral designation to Lenvima™ (lenvatinib) in the identification of patients for Pfizer’s treatment of anatomically accessible oral (Eisai Inc., www.eisai.com/US), a multiple FDA-approved targeted therapy, Xalkori® and pharyngeal cancers, including cancers receptor tyrosine kinase inhibitor, for the (crizotinib). of the lip, tongue, gum, floor of mouth, investigational use in patients with salivary gland, and other oral cavities. advanced or metastatic renal cell carcinoma (RCC) who were previously treated with a • Valor Biotherapeutics, LLC, (www.valorbio. vascular endothelial growth factor (VEGF)- Online Course on Male com) announced that the FDA has approved targeted therapy. Oncofertility an investigational new drug (IND) for This free online video course for the IGN002. The approved IND is a key step in • Delcath Systems, Inc. (www.delcath.com) oncology community explores male allowing Valor to begin a Phase I clinical announced that the FDA has granted orphan fertility preservation. The course study of IGN002 in patients with non- drug designation for melphalan for the includes interviews with a testicular Hodgkin lymphoma (NHL). treatment of cholangiocarcinoma (a tumor cancer survivor, as well as experts in in the bile duct that arises within the liver). the oncology, reproductive medicine, • ImMucin (Vaxil Bio, www.vaxilbio.com) and cryogenics fields. The objective is has been granted FDA orphan drug • BioDelivery Sciences International, Inc. to help oncology providers feel designation for the treatment of multiple (www.bdsi.com) announced that the FDA has comfortable in having the fertility risk myeloma (MM). ImMucin is an immuno- approved an sNDA for a new formulation of conversation with their pediatric, ® therapeutic treatment that educates the Onsolis (fentanyl buccal soluble film) for adolescent, and young adult cancer MM patient’s immune system to attack MM the management of breakthrough pain in patients to maximize the opportunity cancer cells via a specific domain, termed patients with cancer who are opioid tolerant. for fertility preservation. Learn more signal peptide, of the tumor marker MUC1. at www.oncofertu.org. • The FDA has granted fast track designa- • Takeda Pharmaceutical Company Limited tion to Toca 511 and Toca FC (Tocagen Inc., (www.takeda.com) has submitted a new drug www.tocagen.com) for the treatment of application (NDA) to the FDA for ixazomib, recurrent high grade glioma, which includes an investigational oral proteasome inhibitor glioblastoma and anaplastic astrocytoma. Favorable Medicare Final Coverage for the treatment of patients with relapsed Decision for the Polaris® Test and/or refractory multiple myeloma. Devices in the News On Aug. 13, 2015, Myriad Genetics, Inc. • KaloBios Pharmaceuticals, Inc. (www. (www.myriad.com) announced that kalobios.com) announced that the FDA has • Medrobotics Corporation (www. Noridian, the Medicare Administrative cleared the company’s IND application for medrobotics.com) has received FDA market Contractor (MAC) for Myriad, has KB003, an anti-GM-CSF monoclonal clearance to sell its Flex® Robotic System issued a final local coverage determi- antibody (mAb), in patients with chronic in the U.S. nation (LCD) for Prolaris®, myelomonocytic leukemia (CMML). The a prognostic test for assessing the acceptance of this IND allows KaloBios to • Elekta’s (www.elekta.com) Leksell aggressiveness of prostate cancer. initiate an open-label Phase I study designed Gamma Knife® Icon™ radiosurgery system This decision follows a final LCD to evaluate the safety, pharmacokinetics, has received 510(k) clearance from the FDA. decision from Palmetto GBA on Jan. and clinical activity of KB003 in previously 15, 2015. The final LCD is posted to the treated CMML patients. Medicare Coverage Database on the Genetic Tests and Assays in Centers for Medicare & Medicaid • Amgen (www.amgen.com) has submitted a the News Services website with an effective supplemental new drug application (sNDA) to date of Oct. 15, 2015, and provides the FDA for Kyprolis® (carfilzomib) for • Roche (www.roche.com) has submitted Medicare coverage for prostate cancer Injection to seek an expanded indication for its cobas® EGFR Mutation Test v2 for patients defined as low and very low the treatment of patients with a form of blood premarket approval to the FDA as a compan- risk by the National Comprehensive cancer, relapsed multiple myeloma, who have ion diagnostic test for AZD9291, an Cancer Network (NCCN). received at least one prior therapy. Kyprolis AstraZeneca investigational therapy for NSCLC currently has accelerated approval in the U.S. patients with an acquired resistant mutation.

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