tools

Approved Drugs announced that the FDA has approved • Taiho Oncology, Inc. (www.taihooncology. Velcade® (bortezomib) for injection for com) announced that the FDA has granted • Eisai Inc. (www.eisai.com/US) use in previously untreated patients with fast track designation for TAS-102 announced that the Food and Drug mantle cell lymphoma (MCL). This approval (trifluridine and tipiracil hydrochloride), Administration (FDA) has approved extends the utility of Velcade beyond an oral combination anticancer drug under Akynzeo® ( and ) relapsed or refractory mantle cell lym- investigation for the treatment of refractory for the prevention of acute and delayed phoma, for which it has been approved metastatic colorectal cancer (mCRC). nausea and associated with since 2006. initial and repeat courses of cancer Genetic Tests and Assays in chemotherapy, including, but not limited • Medivation, Inc. (www.medivation.com) the News to, highly emetogenic chemotherapy. and Astellas Pharma Inc. (www.asteallas. Akynzeo is a combination oral agent that com/en) announced that the FDA approved • bioTheranostics, Inc. targets two critical signaling pathways a new indication for the use of Xtandi® (www.biotheranostics.com) announced associated with CINV (chemotherapy- (enzalutamide) capsules to treat patients that its Breast Cancer IndexSM test has induced nausea and vomiting) by with metastatic castration-resistant been awarded Medicare coverage. The combining netupitant, an NK1 receptor prostate cancer (CRPC). molecular genomic test quantifies risk of antagonist, and palonosetron, a 5-HT3 breast cancer recurrence and predicts receptor antagonist, in a single capsule Drugs in the News which patients have a high likelihood of for the prevention of CINV. benefitting from extended endocrine • The FDA has granted multiple orphan drug therapy. The Medicare policy covers use of • The FDA granted accelerated approval to designations to aldoxorubicin (CytRx the test to predict risk of late (5 to 10 years) Keytruda® (pembrolizumab) (Merck, Corporation, www.cytrx.com) in three distant recurrence in women with early www.merck.com) for the treatment of indications: glioblastoma multiforme, small stage, estrogen receptor-positive breast patients with advanced or unresectable cell lung cancer, and ovarian cancer. cancer who are considering extended melanoma who are no longer responding to Aldoxorubicin is CytRx’s modified version of therapy but are concerned about continuing other drugs. Keytruda blocks a cellular the widely-used chemotherapeutic agent, anti-hormonal therapy because of pathway known as PD-1, which restricts the doxorubicin. documented toxicity or possible significant body’s immune system from attacking patient-specific side effects. In addition to melanoma cells. The drug is intended for use • DNAtrix, Inc. (www.dnatrix.com) new claims, Medicare coverage and following treatment with ipilimumab, a type announced that the FDA has granted payment for the Breast Cancer Index will of immunotherapy. For melanoma patients orphan drug designation for DNX-2401, be made retrospectively for previously whose tumors express a gene mutation a conditionally-replicative oncolytic submitted claims. called BRAF V600, Keytruda is intended for adenovirus for malignant glioma. use after treatment with ipilimumab and a BRAF inhibitor, a therapy that blocks activity • FDA has granted priority review status for of BRAF gene mutations. the new drug application for lenvatinib mesylate (Eisai Inc., www.eisai.com) as a • Millennium: The Takeda Oncology treatment for progressive radioactive Company (www.millennium.com) iodine-refractory differentiated thyroid cancer.

22 www.accc-cancer.org | November–December 2014 | OI