Junshi Biosciences Reports the NMPA Acceptance of sNDA of Toripalimab as 1L Treatment of Extensive-Stage Small Cell Lung Cancer
Shots:
- The NMPA has accepted the sNDA for review of toripalimab (anti-PD-1 mAb) in combination with etoposide and Pt as 1L treatment of patients with ES-SCLC
- The sNDA was based on a P-III trial (EXTENTORCH) evaluating the efficacy and safety of toripalimab vs PBO in combination with etoposide + Pt in 420 patients. The results showed that combination therapy could significantly prolong the PFS and OS while the safety profile was similar to prior studies & no new safety signals were seen
- The BLA for toripalimab + gemcitabine/cisplatin is under the US FDA’s review as 1L treatment of patients with advanced recurrent or metastatic NPC and toripalimab monotx. for 2L or later treatment of recurrent or metastatic NPC
Ref: Globe Newswire | Image: Junshi
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
