Eli Lilly neKambani nhasi vazivisa kuti US Food and Drug Administration (FDA) yaburitsa tsamba yakakwana yekupindura (CRL) yeBiologics License Application (BLA) yemushonga wekuferefeta sintilimab jekiseni, PD-1 inhibitor yakasanganiswa nepemetrexed uye. platinum chemotherapy yekutanga-mutsara kurapwa kwevanhu vane nonsquamous isiri-diki cell kenza yemapapu (NSCLC). Sintilimab iri kuvandudzwa neInnovent Biologics, Inc. naLilly.
Tsamba iyi inoratidza kuti kutenderera kwekuongorora kwapera asi FDA haikwanise kubvumidza chikumbiro ichi muchimiro chayo chazvino, zvinoenderana nemhedzisiro yeOncologic Drugs Advisory Committee Meeting muna Kukadzi. Iyo CRL inosanganisira kurudziro yekuwedzera chidzidzo chekiriniki, kunyanya muyedzo wekiriniki yenharaunda dzakawanda uchienzanisa chiyero chekurapa kwemutsara wekutanga metastatic NSCLC kune sintilimab nechemotherapy uchishandisa isiri-ipasi dhizaini ine magumo ekupona.
Pamwe chete naInnovent, Lilly ari kuongorora matanho anotevera echirongwa che sintilimab muUS
ZVOKUBVA MUNYAYA INO:
- Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biologics License Application (BLA) for the investigational medicine sintilimab injection, a PD-1 inhibitor in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer (NSCLC).
- The CRL includes a recommendation for an additional clinical study, specifically a multiregional clinical trial comparing standard of care therapy for first line metastatic NSCLC to sintilimab with chemotherapy utilizing a non-inferiority design with an overall survival endpoint.
- The letter indicates that the review cycle is complete but the FDA is unable to approve the application in its current form, consistent with the outcome of the Oncologic Drugs Advisory Committee Meeting in February.
