09/07/2026 CSPC’s B7-H3 ADC SYS6043 secures Breakthrough Therapy Designation in China for platinum-resistant Ovarian cancer CSPC’s B7-H3 ADC SYS6043 secures Breakthrough Therapy Designation in China for platinum-resistant Ovarian cancer (Ref) CSPC Pharmaceutical's antibody-drug conjugate (ADC) SYS6043, targeting B7-H3, has received Breakthrough Therapy Designation from China’s NMPA for platinum-resistant ovarian cancer, primary peritoneal carcinoma, and fallopian tube cancer

08/07/2026 New independent-statistician analyses show DCVax-L survival benefit was underestimated New independent-statistician analyses show DCVax-L survival benefit was underestimated (Ref) Northwest Biotherapeutics presented updated survival data from the Phase 3 trial of DCVax®-L (dendritic cell-based vaccine) for glioblastoma (GBM) at the 2026 BNOS meeting. Survival benefit of DCVax-L was likely underestimated in the original trial analysis New analyses used individual pa

June 4th Week, 2026 Regulatory Updates 🎯 Pfizer's palbociclib (Ibrance; CDK4/6 inhibitor) has been approved in the US for use with trastuzumab (anti-HER2) ± pertuzumab (anti-HER2), and endocrine therapy as 1L maintenance Tx for HR+, HER2+ LA/M breast cancer following induction therapy (Ref 1) ❓ How is Ibrance positioned in the BC market landscape? 🎯 The US FDA approved Gilead Sciences’ sacituzumab govitecan-hziy (Trodelvy; TROP2 ADC) for the 1L Tx of unresectable LA/M TNB

Highlights from the CHMP June 2026 Meeting are out! New Biosimilar Medicines 💊 Ascend GmbH & Enzene Biosciences Ltd's denosumab (Denosumab Ascend; anti-RANKL) is intended for the prevention of bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity Indication Expansions 💊 AstraZenec

07/07/2026 ITM‑11 significantly outperforms everolimus in advanced GEP‑NETs with superior efficacy and safety ITM‑11 significantly outperforms everolimus in advanced GEP‑NETs with superior efficacy and safety (Ref) ITM announced that primary results from its Phase 3 COMPETE trial were published in The Lancet, showing that investigational ¹⁷⁷Lu-edotreotide (ITM-11; SSTR2-targeted peptide receptor radionuclide therapy) significantly improved progression-free survival and respon

02/07/2026 Roche's Divarasib demonstrates superiority over approved KRAS G12C Inhibitors in Phase 3 NSCLC trial Roche's Divarasib demonstrates superiority over approved KRAS G12C Inhibitors in Phase 3 NSCLC trial (Ref) Roche's Phase 3 Krascendo 1 study of divarasib (next-generation KRAS G12C inhibitor) demonstrated statistically significant improvements in both progression-free and overall survival vs approved first generation KRAS G12C inhibitors sotorasib or adagrasib in pa

30/06/2026 BRUKINSA + rituximab achieves 43% PFS risk reduction in frontline MCL US FDA approves Orca Bio’s TREGZI™, as first precision‑engineered cell therapy for matched‑donor stem cell transplant in adult hematological malignancies BRUKINSA + rituximab achieves 43% PFS risk reduction in frontline MCL (Ref) BeOne Medicines announced that BRUKINSA (zanubrutinib; BTK inhibitor) combined with rituximab met the primary progression-free survival endpoint in the Phase 3 MANGROVE

29/06/2026 Genmab & AbbVie's epcoritamab + lenalidomide combination meets primary endpoint of PFS in Phase 3 DLBCL trial Samsung Bioepis’ Keytruda biosimilar SB27 demonstrates Phase 1 and Phase 3 equivalence in NSCLC trials MHRA validates Eisai and Nuvation Bio's taletrectinib MAA in UK, expanding ROS1+ NSCLC access Genmab & AbbVie's epcoritamab + lenalidomide combination meets primary endpoint of PFS in Phase 3 DLBCL trial (Ref) Genmab announced positive topline results from

26/06/2026 Henlius’ serplulimab secures EU approval for sqNSCLC FDA accepts RP1 BLA resubmission for advanced Melanoma; Decision expected by August 2026 FDA grants tentative approval for enzalutamide tablets, adding new dosing strengths to compete with Xtandi Henlius’ serplulimab secures EU approval for sqNSCLC (Ref) The European Commission approved serplulimab (Hetronifly®; anti-PD-1) in combination with chemotherapy for first-line treatment of unresectable locally advanced

24/06/2026 US FDA approved sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer (TNBC) EU approves KEYTRUDA + Padcev as first PD-1 + ADC perioperative regimen for cisplatin-ineligible MIBC IBRANCE secures US FDA approval as the first CDK4/6 inhibitor for HR+, HER2+ metastatic breast cancer maintenance US FDA approved sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizu