Mushonga Mutsva Wekushandisa Kurapa KweGomarara Risiri Diki Sero Remapapu

Mirati Therapeutics, Inc., kambani yekiriniki yakanangana neoncology nhasi yakazivisa kuti US Food and Drug Administration (FDA) yakagamuchira New Drug Application (NDA) yeadagrasib yekurapa varwere vane isiri-diki cell cancer yemapapu (NSCLC) kuchengeta iyo KRASG12C shanduko vakagamuchira kamwechete yekutanga systemic kurapwa. Iyo Prescription Drug User Fee Action (PDUFA) zuva readagrasib ndiZvita 14, 2022.       

Adagrasib NDA iri kuongororwa neFDA yeAccelerated Approval (Subpart H), iyo inobvumira kubvumirwa kwemishonga inorapa zvirwere zvakakomba, uye inozadza chidikanwi chekurapa chisingatarisirwi zvichibva pane imwe nzvimbo yekupedzisira. Pamusoro pezvo, chikumbiro ichi chiri kuongororwa pasi peiyo FDA Real-Nguva Oncology Ongororo (RTOR) mutyairi chirongwa, icho chine chinangwa chekuongorora yakanyatso ongororo maitiro anoita kuti kurapa kwakachengeteka uye kunoshanda kunowanikwa kune varwere nekukurumidza sezvinobvira. Adagrasib yakawanawo Breakthrough Therapy Designation muUS semushonga ungangoita wevarwere vane NSCLC vanochengeta KRASG12C mutation vakagamuchira kamwechete kekutanga systemic therapy.

Pasi A. Jänne, MD, Ph.D., muongorori ari kutora chikamu muongororo yeKRYSTAL-1, uye mutungamiriri weLowe Center yeThoracic Oncology kuDana-Farber Cancer Institute, vakati, “KRAS shanduko dzave nemukurumbira wakaoma kutarisa uye. kare vane nzira dzokurapa dzisina kukwana. Iyo KRASG12C biomarker kunyanya inodyidzana nemararamiro ekupona. Ongororo yeFDA yeadagrasib NDA inocherekedza kufambira mberi kwakakosha pakukwanisa kupa sarudzo nyowani, yakanangwa kune avo vanorarama neKRASG12C-yakashandurwa isiri-diki kenza yemapapu.

"Kugamuchirwa kweDA yedu yeadagrasib inhanho yakakosha kumberi mukuedza kwaMirati kusimudzira nzira itsva, dzakasiyana dzekurapa varwere vane KRASG12C cancer," akadaro Charles Baum, MD, Ph.D., purezidhendi, muvambi uye mukuru weongororo uye Development, Mirati Therapeutics, Inc. "Tinotarisira kushanda neFDA panguva yekuongorora kwavo chikumbiro chedu uye tichigona kupa sarudzo itsva kune varwere vane isiri-diki cell cancer yemapapu."

NDA yakavakirwa pachikamu chechipiri chekunyoresa-chinogonesa boka rezvidzidzo zveKRYSTAL-2, kuongorora adagrasib 1mg BID muvarwere vane NSCLC yepamusoro inochengeta KRASG600C mutation zvichitevera kurapwa kwekutanga neimmunotherapy uye chemotherapy, pamwe chete kana kutevedzana. Kambani yakashuma data rakanaka repamusoro kubva kuboka iri munaGunyana 12, uye inoronga kuunza mhedzisiro pamusangano wekurapa mukati mehafu yekutanga ya2021.

Kambani ine inoenderera mberi yekusimbisa Phase 3 kuyedza, KRYSTAL-12, yekuongorora adagrasib maringe nedocetaxel muvarwere vane mutsara wechipiri KRASG12C-yakashandurwa NSCLC.