https://inthought.com/wp-content/uploads/2019/03/inThought-Logo-Transparent-3.7.png00clickgianthttps://inthought.com/wp-content/uploads/2019/03/inThought-Logo-Transparent-3.7.pngclickgiant2019-08-02 16:42:412019-08-02 16:42:53Phase 3 CheckMate - 227 update in 1L NSCLC: survival benefit with Opdivo/Yervoy but not Opdivo/chemotherapy
Zolgensma is approved for the treatment of pediatric patients less than 2 years of age with SMA including those who are pre-symptomatic at diagnosis.
Zolgensma is designed to address the genetic root cause of SMA by replacing the defective or missing SMN1 gene to halt disease progression with a single, one-time infusion.
Data from the Phase 3 STR1VE trial show prolonged event-free survival, increases in motor function and significant milestone achievement in patients with SMA Type 1, consistent with the Phase 1 START trial.
In the START trial, patients treated with Zolgensma achieved motor milestones never seen in the natural history of the disease, including sitting, talking and some patients walking, with no waning of effect nearly four years post-dosing.
AveXis has an exclusive, worldwide license with Nationwide Children’s Hospital to both the intravenous and intrathecal delivery of AAV9 gene therapy for the treatment of all types of SMA; has an exclusive, worldwide license from REGENXBIO for any recombinant AAV vector in its intellectual property portfolio for the in vivo gene therapy treatment of SMA in humans.
BeiGene has announced that the China NMPA (National Medical Products Administration) has granted Priority Review status to the sNDA for tislelizumab (anti-PD-1; Fc-engineered) for patients with previously treated locally-advanced or metastatic urothelial carcinoma (UC).
The filing is supported by data from a pivotal Phase 2 study in 113 PD-L1+ Chinese and South Korean patients with previously treated locally or metastatic UC.
https://inthought.com/wp-content/uploads/2019/03/inThought-Logo-Transparent-3.7.png00clickgianthttps://inthought.com/wp-content/uploads/2019/03/inThought-Logo-Transparent-3.7.pngclickgiant2019-07-23 15:25:352019-07-23 15:26:36BeiGene’s Tislelizumab Granted Priority Review in China for Urothelial Carcinoma
FDA has granted accelerated approval to Keytruda (pembrolizumab) monotherapy for 3L treatment of metastatic SCLC. According to Keytruda’s revised label, it is indicated for use after platinum-based chemotherapy and one other line of therapy.
This approval is based on pooled data from the KEYNOTE-158 (Phase 2) and KEYNOTE-028 (Phase 1b) trials.
https://inthought.com/wp-content/uploads/2019/03/inThought-Logo-Transparent-3.7.png00clickgianthttps://inthought.com/wp-content/uploads/2019/03/inThought-Logo-Transparent-3.7.pngclickgiant2019-06-28 14:01:402019-06-28 14:01:40Keytruda receives FDA accelerated approval for 3L SCLC
Merck has announced that its Phase 3 KEYNOTE-119 trial assessing Keytruda (pembrolizumab) monotherapy compared to chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine) in 2L and 3L metastatic triple-negative breast cancer (TNBC) patients did not meet the primary endpoint of OS.
In accordance with the study protocol, other endpoints (PFS, ORR, disease control rate, and duration of response) were not formally tested since OS was not met.
Merck plans to present these results at an upcoming medical conference.