8 Oncology Times • 6/25/14 T Breakthrough StatusforElotuzumab&CO-1686 FDA Approval forVectibix &CompanionDiagnostic; tic fortic Vectibix (which detects the most Qiagen N.V., asacompanion- diagnos Kit KRAS test), (therascreen made by proved thetherascreen KRAS RGQ PCR colorectal cancer. FDA The hasalsoap- KRAS metastatic wild-type tients with FOLFOXtreatment asfirst-line for pa- for usein combination with Vectibix (panitumumab) Administration has approved he U.S. Food and Drug chemotherapy (OT ). 12/10/06issue oxaliplatin-, and irinotecan-containing fluoropyrimidine-, treatment with prior cancer after diseaseprogression after EGFR-expressing colorectal metastatic proved patientswith for thetreatment of ap- been previously had antibody,anti-EGFR which KRAS gene). frequent mutations inthe Vectibix human isafully manufactured by Amgen, on isbased KRAS mutation. thewild-type cer with colorectal metastatic patients with can- treatmentfirst-line treatmentfor the of FOLFOXdicated for theusewith in The approvalThe for Vectibix, which is biologic therapy in- biologic the first andonly makes Vectibix drug indication for the This mostrecentThis ASCO Annual Meeting (Abstract 2524). sults from were thetrial presented at the thedrug; re additional - Phase I/IIstudy of onis based interim datafrom anongoing doses.anticipated therapeutic EGFRat tation, wild-type sparing while tion aswelltheT790Mresistance mu- both the initial activation EGFR muta to EGFRdesigned selectively tor target of is anovel, oral, targeted covalent inhibi- disease(ELOQUENT-2).refractory (ELOQUENT-1), aswell asinrelapsed or aredrug now ongoingtreatment asfirst-line multiple myeloma. for the PhaseIIItrials asone treated inpreviously patients with lenalidomide andlow-dosewith dexameth- incombination thedrug two dose levels of Phase II, open-label study that evaluated from onis based findings randomized a not detectabletissue. innormal cells, killer eloma and natural but thatis CS1), a glycoprotein expressed on my Activation Molecule (SLAMF7, alsocalled Lymphocytetargeted Signaling against an investigational monoclonal antibody ing thecommercialization theagent—is of AbbVie, Bristol-Myers with Squibb- lead ment compared existing therapies. with may demonstrate substantial improve clinicalsuggestsearly thedrug evidence or life-threateningserious diseasewhere apotential for new drug of time review created to expedite thedevelopment and FDA’s andInnovation 2012Safety Act, was ceptor mutant cell non-small lung cancer. factor epidermalgrowth remutation with - theT790M patientswith line treatment of therapies;prior and CO-1686 for second- myeloma have who received one or more multiple forelotuzumab patientswith Breakthrough Therapy status— andCO-1686wereelotuzumab given rioration, andintestinal obstruction. Vectibix are generalphysical healthdete- reported serious, adverse reactions of sea, anddiarrhea. mostfrequently The presentations, paronychia, fatigue, nau- of Vectibix variable are with skinrash notresponded had who to chemotherapy. KRAS tumors wild-type in patientswith colorectal metastatic cancertreatment of taking agentcetuximab for as a single the taking Vectibix compared patients with for improving inpatients overall survival non-inferiority endpoint of its primary 19.4 months for FOLFOX alone). (23.8months forvival thecombination vs. improvementa significant in overall sur alone (9.6 months vs. 8 months), as well as FOLFOX FOLFOX compared use of with progression-free with Vectibix survival and two achieved improvements significant in KRAS tumors in exon wild-type tients with PRIME PhaseIIIstudy showed thatfor pa- results from two PhaseIII studies. The The Breakthrough Therapy designation BreakthroughThe Therapydesignation CO-1686, made by Oncology, Clovis Elotuzumab’s breakthrough designation co-developedElotuzumab—being with the designation,The of enacted aspart In other recent FDA actions, both mostcommonThe adverse reactions Also, thePhaseIII met ASPECCT trial

O T - - - -