Inanunsyo ngayon ni Eli Lilly and Company na ang US Food and Drug Administration (FDA) ay naglabas ng kumpletong response letter (CRL) para sa Biologics License Application (BLA) para sa investigational medicine na sintilimab injection, isang PD-1 inhibitor kasama ng pemetrexed at platinum chemotherapy para sa first-line na paggamot ng mga taong may nonsquamous non-small cell lung cancer (NSCLC). Ang Sintilimab ay binuo ng Innovent Biologics, Inc. at Lilly.
Isinasaad ng liham na kumpleto na ang ikot ng pagsusuri ngunit hindi maaprubahan ng FDA ang aplikasyon sa kasalukuyan nitong anyo, na naaayon sa kinalabasan ng Oncologic Drugs Advisory Committee Meeting noong Pebrero. Ang CRL ay may kasamang rekomendasyon para sa karagdagang klinikal na pag-aaral, partikular na isang multiregional na klinikal na pagsubok na naghahambing ng pamantayan ng therapy sa pangangalaga para sa first line metastatic NSCLC sa sintilimab na may chemotherapy na gumagamit ng non-inferiority na disenyo na may pangkalahatang survival endpoint.
Kasama ng Innovent, tinatasa ni Lilly ang mga susunod na hakbang para sa programang sintilimab sa US
ANO ANG DAPAT ALISIN SA ARTIKULONG ITO:
- 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.
