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July 25, 2019 Impact: High Bristol-Myers Squibb has provided updates on Part 1a and Part 2 of the Phase 3 CheckMate -227 study of Opdivo in 1L NSCLC. Part 1a, which evaluated Opdivo and Yervoy vs. chemotherapy, met the co-primary endpoint of overall survival in patients with tumor expression levels of PD-L1 > 1%. A survival benefit […]
July 23, 2019 Impact: High 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, […]
July 23, 2019 Impact: Moderate 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 […]
June 18, 2019 Impact Level: High 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 […]
May 20, 2019 Impact Level: Moderate 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, […]
