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Approved Drugs an immunomodulatory agent, and have This approval is based on the re- demonstrated disease progression on sults of a randomized, double-blind, • The Food and Drug Administration (FDA) or within 60 days of completion of the placebo-controlled, global, multicenter has approved Afinitor® () last . The indication for Kyprolis trial enrolling patients with mCRC that ( Pharmaceuticals Corporation, is based on response rate. Currently, no progressed during or within 6 months of www.novartis.com) in combination with data are available for Kyprolis that dem- receiving -based combination Aromasin (), after failure of onstrate an improvement in progression- , with or without prior treatment with letrozole or anastrozole. free survival or overall survival. . The approval was based on a randomized, double-blind, multicenter trial conducted • Talon Therapeutics (www.talontx.com) Drugs in the News in 724 postmenopausal women with es- announced that Marqibo® (vincristine trogen -positive, HER2-negative, sulfate liposome injection) has • The FDA has granted orphan drug advanced breast cancer with recurrence received accelerated approval from the designation to BAY 94-9343 ( or progression following prior therapy FDA for the treatment of adult patients HealthCare, www.bayer.com), a mesothelin- with letrozole or anastrozole. with negative targeting -drug conjugate (ADC), (Ph-) acute lymphoblastic (ALL) for the treatment of patients with meso- • The FDA approved Erbitux in second or greater relapse or whose thelioma. This investigational agent is () (ImClone LLC, a wholly disease has progressed following two or currently in Phase I clinical development. owned subsidiary of Eli Lilly and Co., more anti-leukemia . This indi- www.lilly.com) for use in combination cation is based on overall response rate. • Biokine Therapeutics Ltd. (www. with FOLFIRI (, 5-, Clinical benefit such as improvement in biokine.com) announced the company has leucovorin) for the first-line treatment overall survival has not been verified. received orphan drug designation from of patients with KRAS mutation-negative the FDA for the mobilization of hemato- (wild-type), EGFR-expressing metastatic • (www.sanofi.com) announced poietic stem cells from bone marrow into (mCRC) as determined that the FDA has approved Zaltrap® peripheral blood for collection and sub- by FDA-approved tests for this use. The (ziv-) injection for sequent transplantation in patients with FDA also approved the therascreen® intravenous infusion in combination with hematological cancers. Earlier in 2012, KRAS RGQ PCR Kit (QIAGEN Manches- 5-fluorouracil, leucovorin, irinotecan Biokine received FDA approval to conduct ter, Ltd., www.qiagen.com) concurrent (FOLFIRI), for patients with metastatic a Phase II clinical study for stem cell with this cetuximab approval. colorectal cancer (mCRC) that is resistant mobilization in multiple myeloma and to or has progressed following an non-Hodgkin patients utilizing • Onyx Pharmaceuticals, Inc., oxaliplatin-containing regimen. BKT140. (www.onyx.com) announced that the FDA Ziv-aflibercept (previously known as has granted accelerated approval of aflibercept) is a recombinant • The FDA has granted orphan drug Kyprolis™ (carfilzomib) for injec- consisting of vascular endothelial growth designation to CNDO-109—activated tion, a proteasome inhibitor indicated for factor (VEGF)-binding portions from the allogeneic natural killer cells (Coro- the treatment of patients with multiple extracellular domains of human VEGF recep- nado Biosciences, Inc., www.coronadobio. myeloma who have received at least two tors 1 and 2 that are fused to the Fc por- com) for the treatment of acute myeloid prior therapies, including bortezomib and tion of the human IgG1 immunoglobulin. leukemia.

www.accc-cancer.org | September–October 2012 | OI 17 Coming This Fall! ACCC’s Oncology Drug Reference Guide This practical publication will be published yearly to help oncologists, nurses, pharmacists, financial counselors, and other oncology support and administrative staff navigate the increasingly complex area of drug information. ACCC’s Oncology Drug Reference Guide is a convenient source of information on the drugs commonly used to treat cancer. Each drug is presented by HCPCS code, generic name, brand name, billing unit, and manufacturer contact information. The guide lists average sales prices for all currently marketed drugs that have Medicare billing codes in the oncology range • Janssen Research & Development, (J8500 through J9600), or that have been approved by the Food and Drug Adminis- LLC, (www.janssenpharmaceuticalsinc. tration for treating cancer. Manufacturers are identified for each brand drug for com) announced that the company has which there is no generic equivalent. submitted a supplemental New Drug Ap- Contact information is included for Association of Community Cancer plication (sNDA) to the FDA for Zytiga® both the reimbursement and medical Centers Oncology (abiraterone acetate). The applica- affairs departments, so that readers Drug tion is intended to extend the use of may request copies of the latest evidence Reference Zytiga administered with prednisone to as well as compendia and journal reprints. Fall 2012, Vol. 1, No. 1 Guide include the treatment of patients with ACCC members will receive a copy metastatic castration-resistant prostate of the Guide in the mail. Quarterly cancer (mCRPC) who are asymptomatic updates will be available on ACCC’s or mildly symptomatic after failure of website (www.accc-cancer.org/drugguide). androgen deprivation therapy and before chemotherapy.

• Bayer HealthCare (www.bayer.com) www.accc-cancer.org/drugguide and Onyx Pharmaceuticals announced that the FDA has granted priority review designation to the company’s new drug application (NDA) for the oral multi- Prostate Health Index (phi), a evidence-based technology platforms kinase inhibitor , for the simple, non-invasive blood test that to determine the genomic information treatment of patients with metastatic is 2.5 times more specific in detecting unique to a patient’s tumor based on the colorectal cancer whose disease has than PSA (prostate- presence of relevant biomarkers. progressed after approved standard specific antigen) in patients with PSA therapies. values in the 4-10 ng/mL range and is Devices in the News proven to reduce the number of prostate • The FDA has completed review of biopsies. Phi will be available in the U.S. • Elekta’s Agility™* multi-leaf colli- Cellceutix Corporation’s (www.cellceutix. in the third quarter of 2012 for use on mator recently received 510(k) clearance com) investigational new drug applica- the company’s Access 2 and UniCel Dxl from the FDA. Agility uses a combination tion (INDA) for Kevetrin™ and informed immunoassay systems. of 160 high-resolution tungsten leaves the company that it may proceed with a and faster leaf movement, precisely proposed Phase I . • Caris Life Sciences (www.carislife sculpting delivered radiation to the sciences.com) announced the launch of unique contours of the tumor, while Assays and Genetic Tests in Caris Target Now™ Select, an ad- reducing the risk of exposure to healthy the News vanced, evidence-based molecular profiling tissue. *Note: Agility is not licensed for service for patients with non-small cell sale in all markets. For details, contact a • Beckman Coulter, Inc., lung cancer (NSCLC), melanoma, and can- local representative. (www.beckmancoulter.com) announced cers of the breast, colon, and ovary. Caris FDA premarket approval (PMA) for the Target Now Select incorporates updated,

18 OI | September–October 2012 | www.accc-cancer.org