Roche PD-1 inhibitor kenza yechiropa yekubatanidza kurapa kwakazivikanwa neDFA senzira yekurapa

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The Swiss Roche Group yakazivisa nezuro izvozvo TECENTRIQ® (atezolizumab) yakabatana neAvastin® (bevacizumab) yakabvumidzwa neUS Food and Drug Administration (FDA) yekubudirira kurapwa kwekutanga (yekutanga-mutsara) kurapwa kwepamusoro kana metastatic chiropa Varwere vane cell carcinoma (HCC).

HCC ndiyo inonyanya kutaurwa mhando yepuraimari gomarara rechiropa . Uku kurapwa kwekubudirira kunoenderana nezvakabuda muChikamu cheIb kudzidza pamusoro pekuchengetedza uye chiitiko chekiriniki cheTECENTRIQ chakabatanidzwa naAvastin.

Dr. Sandra Horning, mukuru wezvekurapa weRoche uye mukuru wezvigadzirwa zvepasirese zvigadzirwa, akati: Hepatocellular carcinoma, sechirwere chakaipa, ine nzira shoma dzekurapa uye ndiyo inonyanya kukonzera rufu pasi rose. Yekutanga data pamusoro pekurapwa kwechirwere ichi neTECENTRIQ uye Avastin iri kuvimbisa. Tinotarisira kushandira pamwe nedhipatimendi rezvehutano kuunza chirongwa ichi chekurapa zvikuru kuvarwere vane hepatocellular carcinoma nekukurumidza.

Breakthrough Therapy Designation (BTD) inovavarira kukwidziridza kuvandudzwa uye kuongororwa kwemishonga mitsva yekurapwa kwezvirwere zvakakomba kana zvinotyisidzira hupenyu kuve nechokwadi chekuti mishonga iyi inogamuchirwa neFDA nekukurumidza sezvinobvira kubatsira varwere. Iyi haisi iyo chete 22nd BTD yakawanikwa neRoche's mishonga chigadzirwa mutsara, asiwo yechitatu BTD yakawanikwa neTECENTRIQ.

Roche Group rakaburitsa data kubva kuChikamu Ib kudzidza kwehepatocellular carcinoma kuAmerican Society yeClinical Oncology (ASCO) musangano wepagore munaJune 2018. Mhedzisiro yechidzidzo yakaratidza kuti mushure mekuteedzana kwemwedzi kwemwedzi gumi, kuregererwa kwakaonekwa mu 10.3 (15%) ye65 varwere vanoongororwa.

After a median follow-up of 10.3 months, the median progression-free survival (PFS), duration of remission (DOR), disease progression time (TTP), and overall survival (OS) were not reached. Of the safety-evaluable patients (n = 43), 28% (n = 12) experienced grade 3-4 treatment-related adverse events, and no treatment-related grade 5 adverse events were observed.

Roche akapa imwezve data zvinoenderana nezvinodiwa neDFA, uye akapihwa budiriro yekurapa. Mushure mekuwana yakagadziridzwa data kubva mukutevera-kwayedza, Roche achashambadza mitsva yekutsvaga pane ramangwana musangano wezvekurapa.

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