Kura Oncology and Kyowa Kirin Report the US FDA’s NDA Acceptance and Priority Review of Ziftomenib for Acute Myeloid Leukemia

Shots:The US FDA has accepted NDA & granted priority review seeking full approval of ziftomenib to treat adults with r/r acute myeloid leukemia (AML) with NPM1 mutation (PDUFA: Nov 30, 2025)NDA is supported by P-II (KOMET-001) trial assessing ziftomenib in r/r NPM1-mutant AML pts, which met its 1EP of CR & CR with…

ByRidhi RastogiJune 2, 2025

News

Merck KGaA to Present P-III (MANEUVER) Trial Data of Pimicotinib for Tenosynovial Giant Cell Tumor at ASCO 2025

Shots:Part 1 of P-III (MANEUVER) trial assessed pimicotinib (n=63) vs PBO (n=31) for 24wks. in 94 TGCT pts who required systemic therapy & had no prior anti-CSF-1/CSF-1R treatment; trial also incl. an open-label Part 2 (data expected in mid-2025) & an OLE phase (Part 3)Trial met its 1EP of improved ORR (54.0% vs…

ByRidhi RastogiMay 28, 2025

News

Genentech Reports P-III (STARGLO) Trial Data on Columvi for R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Shots:Genentech has reported 2yr. P-III (STARGLO) trial data assessing Columvi + GemOx vs Rituxan + GemOx in previously treated ASCT-ineligible r/r DLBCL ptsAt 24.7mos. mFU, trial showed a 40% improvement in OS (mOS: not reached vs 13.5mos.), a 59% reduction in risk of progression or death, & CRs in 58.5% vs 25.3% pts;…

ByRidhi RastogiMay 26, 2025

News

Gilead Reports Topline P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC)

Shots:Gilead has reported topline P-III (ASCENT-03) trial data (n=~540) assessing Trodelvy vs CT in 1L pts with locally advanced, inoperable, or metastatic TNBC without PD-L1 expression or PD-L1+ pts who are previously treated with a PD-L1 inhibitorTrial met its 1EP of improved PFS in treatment-naïve mTNBC pts ineligible for PD-1/PD-L1 inhibitors; OS (2EP) data…

ByRidhi RastogiMay 26, 2025

Kura Oncology and Kyowa Kirin Report the US FDA’s NDA Acceptance and Priority Review of Ziftomenib for Acute Myeloid Leukemia

Merck KGaA to Present P-III (MANEUVER) Trial Data of Pimicotinib for Tenosynovial Giant Cell Tumor at ASCO 2025

Genentech Reports P-III (STARGLO) Trial Data on Columvi for R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Gilead Reports Topline P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC)

Contact US

OUR INFORMATION

FOLLOW US