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Approved Drugs endocrine-based therapy for treatment of approved Xatemp™ (methotrexate) Oral postmenopausal women with hormone Solution, the first and only FDA-approved • The U.S. Food and Drug Administration receptor positive, human epidermal growth methotrexate oral solution. Xatemp is (FDA) granted accelerated approval to factor receptor-2 negative (HR+/HER2-) indicated for the treatment of acute Bavencio® (avelumab) (EMD Serono, Inc., advanced or metastatic breast cancer. lymphoblastic leukemia (ALL) and emdserono.com) for the treatment of polyarticular juvenile idiopathic arthritis patients 12 years and older with metastatic • The FDA expanded the approved use of in pediatric patients. Merkel cell carcinoma. Avelumab is a Stivarga® (regorafinib) to include treatment programmed death-ligand 1 (PD-L1) blocking of patients with hepatocellular carcinoma • Tesaro, Inc. (tesarobio.com) announced human IgG1 lambda monoclonal antibody. (liver cancer) who have been previously that the FDA approved Zejula™ (niraparib), This is the first FDA-approved product to treated with the drug sorafenib. This is the a poly ADP-ribose polymerase (PARP) treat this type of cancer. first FDA-approved treatment for a liver inhibitor, for the maintenance treatment of cancer in almost a decade. adult patients with recurrent epithelial • Pfizer Inc. (Pfizer.com) announced that ovarian, fallopian tube, or primary peritoneal the FDA has approved a supplemental new • The FDA granted regular approval to cancer who are in complete or partial drug application (NDA) for its first-in-class Tagrisso (osimertinib) (AstraZeneca response to platinum-based chemotherapy. cyclin dependent kinase 4/6 (CDK 4/6) Pharmaceuticals, LP, astrazeneca-us.com) for inhibitor, Ibrance® (palbociclib). Ibrance the treatment of patients with metastatic now is indicated in combination with an epidermal growth factor receptor (EGFR) Approved Devices aromatase inhibitor, expanding on its earlier T790M mutation-positive non-small cell indication in combination with letrozole, as lung cancer (NSCLC), as detected by an • Lifetrack Medical Systems Inc. initial endocrine based therapy in post- FDA-approved test, whose disease has (lifetrackmed.com) announced FDA approval menopausal women with hormone progressed on or after EGFR tyrosine kinase of its Lifesys™ PACS, featuring patented receptor-positive (HR+), human epidermal inhibitor therapy. RadNav™ technology, which serves as a growth factor receptor 2-negative (HER2-) guidance system to radiologists through its advanced or metastatic breast cancer. • Genentech (gene.com) announced that integrated decision support system and the FDA granted accelerated approval to active templates. • The FDA approved Keytruda® Tecentriq® (atezolizumab) for the (pembrolizumab) (Merck, merck.com), an treatment of people with locally advanced or • iCAD (icadmed.com) announced that the anti-PD-1 therapy, for the treatment of adult metastatic urothelial carcinoma who are not PowerLook® Tomo Detection received and pediatric patients with refractory eligible for cisplatin chemotherapy. premarket approval from the FDA. This classical Hodgkin lymphoma, or who have concurrent-read computer-aided detection relapsed after three or more prior lines of • The FDA has approved Lexicon Pharma- solution for digital breast 3D tomosynthesis therapy. ceuticals’ (lexpharma.com) Xermelo™ and is the latest innovation available on the (telotristat ethyl) for treatment for PowerLook® Breast Health Solutions • Novartis (novartis.com) announced that diarrhea caused by carcinoid syndrome. platform. the FDA approved Kisqali® (ribociclib, formerly known as LEE011) in combination • Silvergate Pharmaceuticals, Inc. (silver- with an aromatase inhibitor as initial gatepharma.com) announced that the FDA

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