The EMA has received an application for label expansion of Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone to treat adults with mHSPC & HRR gene alterationsSubmission was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered…
Shots:Bio‑Thera reported the dosing of the first patient in a P‑III study assessing the efficacy of BAT8006 vs. the investigator’s choice of single-agent CT in individuals with Pt resistant high‑grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancerEarly clinical Data (N=133; irrespective of FRα expression or treatment history) presented at ASCO’25, from…
Shots:Verastem reported the dosing of the first patient (US) for P-I/IIa study (VS-7375-101) assessing the safety, tolerability, and efficacy of VS-7375The dose-escalation phase of the study starts at 400mg, based on results from a P-I/II study conducted by GenFleet in China, and presented initial safety and efficacy data at ASCO’25Upon reaching the…
Shots:The UK’s MHRA has approved Hetronifly (serplulimab) to treat previously untreated adults in the UK with extensive-stage small cell lung cancer (ES-SCLC)Approval were based on the global P-III (ASTRUM-005) study (n=585) across 128 trial sites, which showed a mFU of 42.4 mos. & 4-year OS rate of 21.9% with serplulimab + CT, confirming its long-term…
Shots:The NMPA has accepted the MAA of Pimicotinib (QD) for adults with TGCT needing systemic therapyThe application was based on Part 1 of the P-III (MANEUVER) global study, 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, the trial also…
Shots:FDA has received NDA of vepdegestrant (ARV-471) to treat pts with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapyNDA was backed by P-III (VERITAC-2) trial assessing ARV-471 alone vs fulvestrant in mentioned pts (n=624) previously treated with CDK4/6 inhibitor + endocrine therapyTrial showed improved PFS (1EP) by 43%…
Shots:The P-III (AMPLITUDE) trial assessed Akeega (niraparib & abiraterone acetate tablet) + prednisone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mCSPC, meeting its 1EP of improved rPFSIn BRCA-altered pts (n=191), trial showed a 48% & 56% reduction in rPFS & symptomatic progression risk, respectively,…
Shots:Roche has reported P-III (IMforte) trial data of Tecentriq + lurbinectedin as 1L maintenance therapy for ES-SCLC pts (≥18yrs)Trial assessed the regimen vs Tecentriq monotx. in ES-SCLC pts, where 660 pts received induction therapy with Tecentriq + CT (4 x 21-day cycles) & 483 pts without progression were then randomized to maintenance with…
Shots:AstraZeneca has shared P-III (MATTERHORN) trial data assessing perioperative Imfinzi + FLOT (n=474) vs PBO + FLOT (n=474) in 948 pts with stage II-IVA G/GEJ cancers at ASCO 2025Pts received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles before surgery followed by Imfinzi (2 cycles with FLOT CT + 10…
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…

