Regeneron says the CHMP has recommended EU approval of an alternative Libtayo dosing schedule: 700 mg every six weeks after an initial 12-week regimen of 350 mg every three weeks. The opinion also supports an optional 15-30 minute infusion for eligible patients. The European Commission decision is expected in the coming months.
The FDA has approved Tecentriq and Tecentriq Hybreza with a fluoropyrimidine and oxaliplatin for adjuvant treatment of stage III dMMR colon cancer, based on the phase III ATOMIC trial.
Roche’s collaborator MediLink reported phase III TAISHAN-302 data showing Tam-Peli (tambotatug pelitecan) reduced the risk of death by 54% versus topotecan in Chinese patients with relapsed small-cell lung cancer, meeting its primary endpoint with a favorable safety profile.
Sanofi’s Sarclisa Escena has been approved by the FDA as the first anticancer treatment deliverable via an on-body injector, offering multiple myeloma patients a faster, needle-free-feeling alternative to IV infusions.
Gilead Sciences announced that the European Commission has approved Trodelvy as a first-line monotherapy for adults with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors, based on the landmark Phase 3 ASCENT-03 study.
Pfizer has announced topline Phase 3 results from its SigVie-002 study evaluating the investigational antibody-drug conjugate sigvotatug vedotin in previously treated metastatic non-squamous non-small cell lung cancer.
Kura Oncology and Kyowa Kirin announced updated frontline data for ziftomenib combined with 7+3 chemotherapy in newly diagnosed NPM1-m and KMT2A-r AML patients, demonstrating high complete response rates and deep MRD negativity ahead of the EHA 2026 Congress.
Pfizer’s Phase 3 TALAPRO-3 trial reveals that combining Talzenna with Xtandi significantly improves radiographic progression-free survival by more than 50% in HRR gene-mutated mCSPC patients.
Johnson & Johnson has announced groundbreaking Phase 3 results for Tecvayli Multiple Myeloma Treatment, demonstrating its superiority over standard-of-care therapies in improving overall survival as early as the first relapse.
AbbVie’s DECNUPAZ FDA approval provides a critical therapeutic lifeline for adult patients diagnosed with blastic plasmacytoid dendritic cell neoplasm (BPDCN). This ultra-rare and highly aggressive [Read More…]
