FDA Inotendera Fotivda yeKiyo Kenza

Nzira yemarapirwo anoitwa covid-19

Sekureva kwaAveo Oncology, Iyo Chikafu neDrug Administration (FDA) musi wa10 Kurume 2021 yakabvumidza Fotivda (tivozanib) kurapwa kwevakuru vane kudzoka kana kuramba. kenza yeitsvo yakanyanya (renal cell carcinoma) vakagamuchira maviri kana anopfuura ekutanga systemic therapies.

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AVEO Oncology (Nasdaq: AVEO) nhasi yazivisa kuti iyo US Chikafu neDrug Administration (FDA) yabvumidza FOTIVDA® (tivozanib) yekurapa vanhu vakuru vakadzokazve kana kuramba vachirapa renal cell carcinoma (RCC) vakagamuchira maviri kana anopfuura epamberi maitiro ekurapa. FOTIVDA inotaurwa, inotevera-chizvarwa vascular endothelial kukura chinhu (VEGF) tyrosine kinase inhibitor (TKI).

"Kubvumidzwa kwanhasi kweFOTIVDA kunopa chishandiso chitsva chekurapa varwere vane gomarara reitsvo avo vadzokazve kana kuramba kuita maviri kana kupfuura marapirwo ehurongwa," akadaro Brian Rini, MD, Chief of Clinical Trials kuVanderbilt Ingram Cancer Center uye mupurisa mukuru we TIVO-3 kuyedzwa. 

"Nekufambira mberi mukurapa kweRCC, varwere vari kurarama kwenguva yakareba, vachiwedzera kudiwa kwenzira dzakaratidzwa, dzakabvumirwa zvakanaka pakurapa kwakadzokororwa kana kwekufungidzira. Chidzidzo cheTIVO-3 ndiyo yekutanga yakanaka Phase 3 kudzidza muRCC varwere vakagamuchira maviri kana anopfuura epamberi maitiro ekurapa, uye zvakare yekutanga Phase 3 RCC kudzidza kusanganisa yakatemerwa huwandu hwevarwere vakagamuchira pre immunotherapy, iyo yazvino chiyero chekutarisira mune yekutanga-mutsara kurapwa. Nemvumo iyi, ndinotenda FOTIVDA inomiririra kupindira kunoyevedza, uye ndinotarisira kuti ichaita basa rakakosha mukushanduka kwenzvimbo yekurapa yeCCC. "

"Tinotenda mukugona kweFOTIVDA kupa nzira yekusiyanisa yekurapa kwehuwandu huri kukura hwevanhu muUS vane RCC vakadzokazve kana kuramba, uye nhasi uno mucherechedzo wemakore mazhinji ekushanda nesimba uye kutsunga kwevanhu vazhinji kuunza kurapwa uku kuvarwere, "Akadaro Michael Bailey, mutungamiri uye mukuru mukuru weDOO. "Nemvumo yanhasi, AVEO inotanga rwendo rayo sekambani yekutengesa-chikamu, chiitiko chinoshamisa muindasitiri yedu. Ndichimiririra timu yese yeDAO, ndinoda kutenda varwere vese, mhuri dzavo, nevachengeti avo nekushingairira kwavo vakaita kuti zuva iri rikwanisike. ”

"Kudzoka kana kukanganisa RCC chirwere chinoparadza icho mhedzisiro yevarwere inogona kudzikiswa nekuda kwekushambadzira pakati pekushivirira nekubudirira," akadaro Dena Battle, purezidhendi weKCCure. "Kubvumidzwa kweFDA neFOTIVDA kunomiririra budiriro inonakidza, inonzwisisika nekupa imwe nzira yekurapa kune varwere ava."

AVEO inoronga kuita kuti FOTIVDA iwanikwe kune varwere muUS naKurume 31, 2021.

Kubvumidzwa kweFOTIVDA kunoenderana neiyo AVEO yakakosha Chikamu chechitatu kudzidza, TIVO-3, ichifananidza FOTIVDA ne sorafenib mune yakadzokororwa kana yekumbomira yepamusoro RCC ichitevera maviri kana anopfuura epamberi maitiro ekurapa. Iko kunyorera kunotsigirwawo nemimwe miedzo mitatu muRCC uye inosanganisira data rekuchengetedza kubva kunopfuura chiuru chemakiriniki ekuyedza zvidzidzo.

Varwere (n = 350) vakanyoresa muTIVO-3 kudzidza vakasarudzika 1: 1 kuti vagamuchire kana FOTIVDA kana sorafenib. Iyo hombe yekubudirira mhedzisiro chiyero kwaive kufambira mberi-kwemahara kupona (PFS), yakaongororwa nekapofumara yakazvimiririra yakazvimirira radiology ongororo komiti. Dzimwe dzekupedzisira magumo aive ekupona kwese (OS) uye chinangwa chekupindura mwero (ORR).

Median PFS yaive 5.6 mwedzi (95% CI: 4.8, 7.3) muFOTIVDA ruoko (n = 175) uchienzaniswa nemwedzi 3.9 (95% CI: 3.7, 5.6) kune avo vanorapwa ne sorafenib (HR 0.73; 95% CI: 0.56 , 0.95; p = 0.016). Median OS yaive 16.4 (95% CI: 13.4, 21.9) uye 19.2 mwedzi (95% CI: 14.9, 24.2), yeFOTIVDA uye sorafenib maoko, zvichiteerana (HR 0.97; 95% CI: 0.75, 1.24). Iyo ORR yaive 18% (95% CI: 12%, 24%) yeiyo FOTIVDA ruoko uye 8% (95% CI: 4%, 13%) yeiyo sorafenib ruoko.

Iwo akajairika (-20%) maitiro akashata aive kuneta, hypertension, manyoka, kushomeka kwekuda kudya, kuda kurutsa, dysphonia, hypothyroidism, kukosora, uye stomatitis. Iyo yakajairika giredhi 3 kana 4 murabhoritari isina kujairika (≥5%) yakadzikira sodium, yakawedzera lipase, uye yakaderera phosphate.

Iyo yakakurudzirwa tivozanib dosi ndeye 1.34 mg kamwe pazuva nezuva kana kana pasina chikafu kwemazuva makumi maviri nerimwe mazuva makumi maviri nemasere pakurapwa kuchiteverwa nemazuva manomwe kubva pakurapwa (21 zuva kutenderera) kudzamara kuchirwara kwechirwere kana chepfu isingagamuchirike.

Musangano Wenhare uye Webcast Ruzivo

Mukubatana nechiziviso ichi, AVEO ichagamuchira musangano wekufona uye slide webcast nhasi, Kurume 10, 2021, na6: 00 PM Eastern Time. Iko kufona kunogona kuwanikwa nekufona (844) 882-7841 (US neCanada) kana (574) 990-9828 (wepasi rese). Iyo passcode yemusangano wekufona ndeye 4648498. Kuti uwane iyo yepamhepo webcast uye inoperekedza slide show, kana inotevera yakachengetwa yekurekodha, ndapota shanyira chikamu chevaInvestors cheiyo AVEO webhusaiti pa www.rweo.com. Iyo webcast icharekodwa uye inowanika kutsiva pawebhusaiti ye AVEO kwemavhiki maviri.

Nezve FOTIVDA® (tivozanib)

FOTIVDA® (tivozanib) ndeyemuromo, inotevera-chizvarwa vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). Iyo ine simba, inosarudza inhibitor yeVEGFRs 1, 2, uye 3 ine hafu yakareba yehupenyu yakagadzirirwa kuvandudza kushanda uye kushivirira. AVEO yakagamuchira mvumo yeUS Food and Drug Administration (FDA) yeFOTIVDA musi waKurume 10, 2021 yekurapa varwere vakura vane kudzokazve kana kuramba. Renal cell carcinoma (RCC) kutevera maviri kana anopfuura ekare systemic therapies. FOTIVDA yakabvumidzwa muna Nyamavhuvhu 2017 muEuropean Union nedzimwe nyika dziri munharaunda yemumwe wayo EUSA Pharma (UK) Limited kurapwa kwevarwere vakuru vane RCC yepamusoro. FOTIVDA yakaratidzwa kudzikisa zvakanyanya kudzora kugadzirwa kweT-sero mune preclinical modhi1. FOTIVDA yakawanikwa naKyowa Kirin.

INDICATIONS

FOTIVDA inoratidzirwa yekurapa kwevakuru varwere vane vakadzokazve kana kusagadzikana kwepamberi renal cell carcinoma (RCC) ichitevera maviri kana anopfuura epamberi maitiro ekurapa.

INOKOSHA INFORMATION INFORMATION

YAMBIRO NEZVOZVO

Hypertension uye HypertensiveCrisis: Chengetedza kuwedzera kweropa usati watanga FOTIVDA. Chengetedza hutachiona hwehutachiona uye kurapa sezvinodiwa. Nekuramba uine hutachiona hwepamusoro kunyangwe uchishandisa anti-hypertensive mishonga, inoderedza iyo FOTIVDA dose.

Kukundikana Kwemwoyo: Chengetedza zviratidzo kana zviratidzo zvekushaya kwemoyo mukati mekurapa neFOTIVDA.

Cardiac Ischemia uye Arterial Thromboembolic Zviitiko: Nyatsoongorora varwere vari pangozi yakakura yezviitiko izvi. Kurega zvachose FOTIVDA yeakakomba arterial thromboembolic zviitiko, senge myocardial infarction uye sitiroko.

Venous Thromboembolic Zviitiko: Nyatsoongorora varwere vari pangozi yakakura yezviitiko izvi. Chirega zvachose FOTIVDA yezviitiko zvakakomba zvine venous thromboembolic.

Hemorrhagic Zviitiko: Nyatsoongorora varwere vari panjodzi kana vane nhoroondo yekubuda ropa.

Proteinuria: Chengetedza mukati mekurapa neFOTIVDA. Kuti uwane proteinuria yakaenzana kusvika pakati, deredza dosi kana kumisa kurapwa kwenguva pfupi neFOTIVDA.

Utachiona Kusashanda: Chengetedza usati watanga uye nekurapwa kwese neFOTIVDA.

Ngozi Yekutadza Kakuvara Kukuvara Kurapa: Bvisa FOTIVDA kwemazuva makumi maviri nemasere vasati vavhiyiwa. Usatongese kweanenge mavhiki maviri zvichitevera kuvhiyiwa kukuru uye kurapa kwakakwana kweronda. Kuchengetedzwa kwekutangazve kweFOTIVDA mushure mekugadziriswa kwemaronda ekuporesa matambudziko hakuna kusimbiswa.

Inodzoserwa Posterior Leukoencephalopathy Syndrome (RPLS): Rega FOTIVDA kana zviratidzo kana zviratidzo zveRPLS zvikaitika.

Embryo-Fetal Chefu: Zvinogona kukonzera kukuvara kwechibereko. Raira varwere nezve njodzi ingangoitika kumucheche uye kushandisa nzira dzekudzivirira nadzo dzinoshanda.

Allergic Reaction kuTartrazine: Iyo 0.89 mg capsule yeFOTIVDA ine FD & C Yero Nha. 5 (tartrazine) iyo inogona kukonzeresa kurwisa kwemhando (kusanganisira bronchial asthma) mune vamwe varwere vanokanganisa.

ZVAKAITIKA ZVAKAITIKA

Iwo akajairika (≥20%) maitiro akashata aive kuneta, hypertension, manyoka, kushomeka kwekuda kudya, kuda kurutsa, dysphonia, hypothyroidism, kukosora, uye stomatitis, uye akajairika eGiredhi 3 kana 4 murabhoritari kusagadzikana (≥5%) yaive sodium yakaderera, lipase yakawedzera, uye phosphate yakaderera.

ZVINODZVIRIRWA ZVINODZIDZWA

Yakasimba CYP3A4 Inducers: Dzivisa hutungamiriri hweFOTIVDA ine yakasimba CYP3A4 inducers.

SHANDISA MUVANHU VAKANAKA

Kuyamwisa Raira kuti usayamwisa.
Vakadzi nevarume veKubereka: Inogona kukanganisa kubereka.
Hepatic Kukanganiswa: Chinja muyero kune varwere vane mwero hepatic kukanganisika. Dzivisa kushandiswa kune varwere vane zvakanyanya kukanganiswa kwehepatic.

Kuti utaure SUSPECTED ADVERSE REACTIONS, bata AVEO Pharmaceuticals, Inc. pa1-833-FOTIVDA (1-833-368-4832) kana FDA pa1-800-FDA-1088 kana www.fda.gov/medwatch.

Ndokumbira kuti uone FOTIVDA Yakazara Runyorwa Ruzivo iyo inowanikwa pa www.AVEOoncology.com.

Nezve Yepamberi Renal Cell Carcinoma

Sekureva kwenhamba dzeAmerican Cancer Society dze2021, renal cell carcinoma (RCC) ndiyo inonyanya kuzivikanwa kenza yeitsvo, iri pakati pekenza gumi dzinowanzozivikanwa muvarume nevakadzi. Vanenge 73,750 mitsva mitsva yekenza yeitsvo ichaonekwa gore rega uye vanhu vangangosvika zviuru gumi nezvina nemazana matatu nemakumi matatu vanofa nechirwere ichi. Mune varwere vane chirwere chekupedzisira-chikamu, makore mashanu ekupona mwero ndeye 14,830%. Agents anotarisa iyo vascular endothelial kukura chinhu (VEGF) nzira yakaratidza yakakosha antitumor chiitiko muRCC.2 Zvinoenderana nechinyorwa che2019, 50% yevarwere vangangoita zviuru gumi vanofambira mberi vachitevera mitsara miviri kana yakawanda yekurapa vanosarudza kusagamuchira kumwe kurapwa,3 izvo zvinogona kuve zvinokonzerwa nekushushikana kunetsekana uye kushomeka kwedata kutsigira humbowo-hwakavakirwa pakurapa zvisarudzo mune ino yakadzokororwa zvakanyanya kana inoratidzira huwandu hwevarwere.

Nezve AVEO Pharmaceuticals, Inc.

AVEO ikambani inoratidzira oncology-yakatarisa biopharmaceutical yakazvipira kuendesa mishonga inopa hupenyu huri nani kune varwere vegomarara. Sangano reDAO ndere kutarisisa zviwanikwa zvaro mukuvandudza uye kushambadzira kwevagadziri vezvigadzirwa kuNorth America, uku vachisimbisa kudyidzana kutsigira kusimudzira nekutengesa mune mamwe mageographies. Mumiriri we AVEO anotungamira, FOTIVDA® (tivozanib), akagashira US Chikafu neDrug Administration (FDA) mvumo munaKurume 10, 2021 yekurapwa kwevarwere vakura vane renal cell carcinoma (RCC) yakadzokororwa (RCC) zvichitevera maviri kana anopfuura epamberi pekurapa kwese. FOTIVDA® yakatenderwa muna Nyamavhuvhu 2017 muEuropean Union nedzimwe nyika dziri muEUSA ndima yekurapa varwere vakuru vane RCC yepamusoro. AVEO yakambotaura kuvimbisa kwekutanga kiriniki dhata pane ficlatuzumab (anti-HGF IgG1 mAb) mumusoro nekenza yemutsipa, kenza yepancreatic uye yakaoma myeloid leukemia uye iri kuitisa yakasarudzika Phase 2 inosimbisa kiriniki kutongwa kweficlatuzumab yeiyo inogona kurapwa yekenza yemusoro neyemutsipa. . Mapaipi eDOO evanogadza zvigadzirwa anosanganisirawo AV-380 (anti-GDF15 IgG1 mAb). AVEO yakamborondedzera kugamuchirwa kwekutsvaga kwayo nyowani yekushandisa zvinodhaka muUS yeAV-380 uye kutanga kwayo Phase 1 kiriniki kutongwa kwekugona kurapwa kwekenza cachexia. Mapaipi epakutanga-eDAO anosanganisira monoclonal antibodies mukuvandudza oncology, kusanganisira AV-203 (anti-ErbB3 mAb) uye AV-353 (anti-Notch 3 mAb). AVEO yakazvipira kuumba nharaunda yekusiyana uye kuiswa.

Yambiro Yekucherechedza Nezve Mberi Kutarisa Zvinyorwa

Ichi chinyorwa chinoburitsa chine zvirevo zvinotarisa kumberi zveDOO mukati mezvinoreva iyo Private Securities Litigation Reform Act ya1995 iyo inosanganisira njodzi dzakakomba nekusaziva. 

Zvese zvirevo, zvimwe kwete zvirevo zvezvakaitika, zviri mune iri kuburitswa zvirevo zviri kumberi. Mazwi ekuti "tarisira," "tenda," "tarisira," "tariro," "funga," "ita," "ronga," "kugona," "kugona," "kufanirwa," "kuda," "Tarisira kumberi," "kumberi," "chinangwa," "zano," kana zvisakarurama zvemazwi aya kana zvimwe zvakafanana zvirevo, zvinoitirwa kuratidza zvirevo zvinotarisa kumberi, kunyangwe zvisiri zvirevo zvese zviri pamberi zvine mazwi ekuzivisa. 

Aya mazwi anotarisa-mberi anosanganisira, pakati pevamwe, zvirevo pamusoro pe: AVEO yakarongwa nguva yekuita FOTIVDA kuwanikwa kune varwere muUS; mukana weFOTIVDA senzira yekurapa yevarwere vakadzokerazve / vanodzora kana vemberi RCC; kugona kushanda, kuchengetedzeka, uye kushivirira kweFOTIVDA, ese seanomira-oga musarudzo yemushonga uye pamwe ne immunotherapy; AVEO kuitiswa kwayo kiriniki uye inodzora zano yeFOTIVDA; Zvirongwa zveDAO uye marongero eazvino uye emangwana emakiriniki ekuedzwa kweFOTIVDA, ficlatuzumab uye AV-380 uye yekutengesa yeFOTIVDA muUnited States; kufambira mberi kwepaipi re AVEO, kusanganisira kufambira mberi kweficlatuzumab mune dzakawanda kiriniki zvidzidzo; kugona kushanda, kuchengetedzeka uye kushivirira kweficlatuzumab, zvese semunhu anomira-oga musarudzo yemushonga uye akabatana nemamwe marapirwo; zvingangoitika mhedzisiro kubva kuzvidzidzo zve ficlatuzumab yekupa AVEO mikana yekutevera nzira dzekutonga; iyo inogona kurapwa kiriniki ye ficlatuzumab munzvimbo dzisingagadzirisike kudiwa; uye zano reDAO, tarisiro, zvirongwa uye zvinangwa kune avo vanogadzira zvigadzirwa uye nekambani kazhinji. 

AVEO yakavakira zvainotarisira uye fungidziro pane fungidziro dzinogona kuratidza kunge dzisiri idzo. Nekuda kweizvozvo, vaverengi vanonyeverwa kuti vasavimbe zvisina kukodzera pane izvi zvinotarisirwa uye fungidziro. 

Chaizvoizvo mhedzisiro kana zviitiko zvinogona kusiyanisa nehunhu kubva pazvirongwa, zvinangwa uye zvinotarisirwa zvakaburitswa mune zvirevo zvinotarisa kumberi izvo zvinoitwa neDOO nekuda kwezvakakosha zvinhu, zvinosanganisira njodzi dzine chekuita ne: kugona kweDOO kubudirira kuita zvirongwa zvehurongwa, kusanganisira kugona kwayo kubudirira kushambadzira FOTIVDA uye kuwana nekuchengetedza musika uye wechitatu mubhadharo mubhadharo kugamuchirwa kweFOTIVDA; Kugona kwe AVEO kukwidza mari yakawedzerwa inodiwa kuti ubudirire kushambadzira FOTIVDA; Kugona kweDAO, uye kugona kwevane marezinesi, kuratidza kugutsikana kwemasangano anomiririra akadai seDFA kuchengetedzeka, kushanda pamwe nekubatsira kwechipatara kwevamiriri vezvigadzirwa zveDOO, nenjodzi dzine chekuita nenguva nemitengo yekutsvaga nekuwana mvumo yekutonga. ; Kuvimba kwe AVEO kune yechitatu-bato vatengesi mukusimudzira, kugadzira uye kuendesa kweFOTIVDA uye nevamiriri vayo vechigadzirwa; Kugona kweDAO kupinda nekuchengetedza zvibvumirano zvebato rechitatu uye zvibvumirano zverayisensi, uye kugona kwayo, uye kugona kwevanobata pamwe navo, kuzadzisa zvinangwa zvebudiriro nekutengesa pasi pegadziriro idzi; AVEO uye avo vanobatsirana navo kugona kunyatso kunyoresa uye kupedzisa kiriniki miedzo; Kugona kwe AVEO kuchengetedza kutevedzera zvinodiwa nemutemo zvinoshanda kuFOTIVDA nevamiriri vayo vechigadzirwa; Kugona kweDAO kuwana nekuchengetedza zvakakwana kuchengetedzwa kwekodzero dzepfuma zvine chekuita neFOTIVDA nevamiriri vayo vechigadzirwa; zvisina kudiwa capital capital; kusava nechokwadi kwakanangana nekwaniso yeDOO yekuwana zvikwereti zvenguva yemberi pasi pechikwereti cheHercules, izvo zvinotendeuka kuzadzikiswa kwezviitiko zvine chekuita nekutenderwa nekutengeswa kweFOTIVDA kuUS; mamiriro akashata ehupfumi, ezvematongerwo enyika, uye emabhizimusi mamiriro. zvinokonzeresa zvinokonzeresa zve COVID-19 denda pane kuenderera kwe bhizinesi kweDOO, mamiriro emari, mhedzisiro yekushanda, kushomeka uye kugona kubudirira uye nenguva kunyoresa, kupedzisa uye kuverenga-kunze data kubva kumakiriniki ayo ekuedzwa; kukwikwidza zvinhu; nenjodzi idzo dzakakurukurwa muzvikamu zvakanzi "Risk Factors" uye "Management Yenhaurirano uye Ongororo yeMari Mamiriro uye Mhedzisiro Yekushandisa - Liquidity uye Capital Zviwanikwa" zvakabatanidzwa mumishumo ye AVEO yekota yegore neyegore pane faira neSecurities and Exchange Commission (SEC) uye mune mamwe mafirita ayo AVEO anogadzira neSec. 

Zvitarisiko zvinotarisisa zviri pamberi peizvi zvinoburitsa zvinomiririra maonero e AVEO sezuva renhau iri, uye zviitiko zvinotevera pamwe nezviri kuitika zvinogona kukonzera kuti maonero aro achinje. 

Nepo AVEO ingangosarudza kugadzirisa zvirevo zvinotarisa kumberi pane imwe nguva mune ramangwana, zvinonyatso tarisa chero chisungo chekuzviita. Iwe haufanire, saka, kusavimba izvi zvirevo zvinotarisa kumberi sekumiririra maonero eDOO sechero rimwe zuva risiri iro zuva rekuburitswa iri.

Chero chinongedzo cheiyo AVEO kero webhusaiti mune ino yekuburitsa inotarisirwa kuve isingashande zvinyorwa zvinyorwa chete uye kwete inoshanda hyperlink.

References:

  1. Pawlowski N et al. AACR 2013. Chikwangwani 3971
  2. J Angulo naO Shapiro, Cancers (Basel) 2019 Sep; 11 (9): 1227. [10.3390 / kanzira11091227]
  3. Sarudzo Zviwanikwa. RCC mamiriro uye fungidziro. Zvita 12, 2019.

Contacts

AVEO Ruzhinji Rwehukama Kubatana:
David Pitts, Argot Partner
(212) 600-1902
aveo@argotpartners.com

AVEO Investor Relations Bata:
Hans Vitzthum, LifeSci Advisors
(617) 430-7578
hans@lifesciadvisors.com