14/09/2026 US FDA reduces IMDELLTRA monitoring time to 6–8 hours, expanding Community Oncology Access BioNTech & Onco4's gotistobart doubled mOS vs docetaxel in non-pivotal part of the Ph3 PRESERVE-003 trial US FDA grants Breakthrough Therapy Designation to RASONQUE™ (daraxonrasib) + chemotherapy for first‑line metastatic pancreatic cancer In the Ph3 DESTINY-Lung04 trial, trastuzumab deruxtecan improved median PFS by 6 months vs pembro + chemo, in 1L HER2-mutant NSCLC pts Pos

24/08/2026 EC Expands Trodelvy + Keytruda Approval to First-Line Metastatic TNBC Across PD-L1 Status US FDA accepts Jemperli for priority review in dMMR/MSI-H rectal cancer US FDA Fast Track designation granted for ERAS-0015 in metastatic pancreatic cancer; Phase 3 trial planned EC Expands Trodelvy + Keytruda Approval to First-Line Metastatic TNBC Across PD-L1 Status (Ref) European Commission’s expanded approval of Gilead’s Trodelvy (sacituzumab govitecan-hziy; Trop-2–directe

28/07/2026 Ris‑Rez achieves landmark Phase III PFS benefit in relapsed osteosarcoma FDA clears path for registrational Phase 2 of CLN-049 in AML Insilico Medicine's ISM6331 Earns US FDA Fast Track Designation for Advanced Mesothelioma Ris‑Rez achieves landmark Phase III PFS benefit in relapsed osteosarcoma (Ref) GSK's licensing partner Hansoh Pharma reported that its ARTEMIS-011 phase III trial of risvutatug rezetecan (Ris-Rez; B7-H3-targeted ADC) met the primary endpoint of

22/07/2026 Ivonescimab plus chemotherapy delivers consistent overall survival gains across Western and Asian NSCLC patients, reinforcing FDA‑filed Phase III HARMONi data US FDA grants Priority Review for talazoparib + enzalutamide in HRR‑mutated mCSPC, with a decision expected in Q4 2026 US FDA Accepts NDA for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer GSK's Jideytro (zidesamtinib) Gets US FDA Approval for ROS1-Positive Lung Cancer Ivonescimab plus chemot

13/07/2026 FDA accepts BMS’s NDA for mezigdomide in relapsed/refractory Multiple Myeloma GSK’s dostarlimab (aPD-1) delivers sustained complete responses in dMMR/MSI-H rectal cancer FDA accepts BMS’s NDA for mezigdomide in relapsed/refractory Multiple Myeloma (Ref) The US FDA has accepted Bristol Myers Squibb’s New Drug Application (NDA) for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) for relapsed/refractory multiple myeloma (RRMM) A Prescription Dru

10/07/2026 FDA rejects Elevar’s rivoceranib + camrelizumab HCC NDA due to manufacturing compliance Risvutatug Rezetecan delivered first Phase III overall survival benefit vs topotecan, in relapsed small cell lung cancer FDA rejects Elevar’s rivoceranib + camrelizumab HCC NDA due to manufacturing compliance (Ref) Elevar Therapeutics announced on that the FDA declined to approve its combination therapy of rivoceranib (VEGFR TKI) and camrelizumab (anti–PD-1) as a first-line trea

07/05/2026 Pierre Fabre secures FDA alignment to resubmit tabelecleucel BLA with updated ALLELE Phase 3 data for EBV+ PTLD Halozyme Announces Global Collaboration and License Agreement with GSK for the first ADC-focused ENHANZE, targeting subcutaneous oncology formulations and milestone-driven royalties Pierre Fabre secures FDA alignment to resubmit tabelecleucel BLA with updated ALLELE Phase 3 data for EBV+ PTLD (Ref) Pierre Fabre Pharmaceuticals (PFP) aligned with the FDA o

10/12/2025 GSK's risvutatug rezetecan received the FDA orphan drug designation for SCLC Ajax Therapeutics' AJ1-11095 received the FDA orphan drug designation for myelofibrosis GSK's risvutatug rezetecan received the FDA orphan drug designation for SCLC (Ref) The US FDA granted the orphan drug designation to GSK's risvutatug rezetecan (B7-H3-targeted ADC) for the treatment of small-cell lung cancer (SCLC). The ODD was based on preliminary clinical data of the Phase 1 ARTEMIS-0

27/10/2025 Cellectar Biosciences' iopofosine I131 received the rare pediatric drug designation for pediatric high-grade glioma (Ref) The US FDA granted the rare pediatric drug designation (RPDD) to Cellectar Biosciences' iopofosine I131 in inoperable R/R pediatric high-grade glioma (pHGG). The FDA previously granted Orphan Drug Designation for iopofosine I 131 for the treatment of pHGG James Caruso, President and CEO, Cellectar: “Receiving Rare Pediatric Disease Designation f

Highlights from the CHMP May 2025 Meeting are out! ⭐ New Medicines 💊 Autolus Therapeutics' obecabtagene autoleucel (Aucatzyl; CD19 CAR-T cell therapy) for the treatment of adults from 26 years of age with R/R B cell precursor acute lymphoblastic leukaemia 👉 Positive opinion recommending the granting of a conditional marketing authorisation 💊 GSK's belantamab mafodotin (Blenrep; anti-BCMA ADC) for the treatment of adults with R/R multiple myeloma: 👉In combination with bort

15/05/2025 Another TIGIT agent fails as iTeos and GSK terminate the belrestotug development program based on disappointing NSCLC and SCCHN trials (Ref 1, Ref 2) iTeos Therapeutics and GSK announced topline results from an updated interim analysis of the Ph2 GALAXIES Lung-201 trial of iTeos & GSK's belrestotug (anti-TIGIT) + GSK & Anaptys' dostarlimab (anti-PD-1) as a first-line Tx of unresectable, locally advanced or metastatic NSCLC with PD-L1 ≥50%, in which clinically meani