13/09/2026 First-time outcomes from the failed Ph3 EVOKE-03 study of sacituzumab govitecan-hziy+ pembro in Tx naive PD-L1 ≥50% NSCLC pts presented at WCLC'26 First-time outcomes from the failed Ph3 EVOKE-03 study of sacituzumab govitecan-hziy+ pembro in Tx naive PD-L1 ≥50% NSCLC pts presented at WCLC'26 (abstract #PL02.06; Ref) The first reported efficacy and safety outcomes from the Ph3 KEYNOTE-D46/EVOKE-03 trial of Gilead's sacituzumab govitecan-hziy (SG; TROP2 ADC) + Merck

08/09/2026 Imfinzi + Imdelltra demonstrated significant benefit in 1st‑line ES‑SCLC maintenance In registrational Phase 2 QUINTESSENTIAL trial, GPRC5D CAR T therapy (arlo‑cel) achieved significant ORR improvement in heavily pretreated multiple myeloma INBRX‑106 + pembrolizumab elicited strong ORR signal in Phase 2 part of Ph2/3 HexAgon-HN trial, driving expansion and FDA‑aligned path to Phase 3 confirmatory trial in HNSCC Imfinzi + Imdelltra demonstrated significant benefit i

02/09/2026 Ivonescimab demonstrated OS benefit vs pembrolizumab in PD‑L1+ NSCLC Ivonescimab demonstrated OS benefit vs pembrolizumab in PD‑L1+ NSCLC (Ref) Summit Therapeutics announced that in a Phase 3 HARMONi-2 China study, ivonescimab monotherapy demonstrated a statistically significant overall survival (OS) benefit vs pembrolizumab in PD-L1–positive advanced NSCLC patients Ivonescimab previously showed a strong progression-free survival (PFS) benefit (HR 0.51; p<0.0001) A

27/08/2026 US FDA granted Fast track designation for Varseta-M in R/R Colorectal Cancer FDA clears path for Phase III melanoma trial of ruxotemitide + pembrolizumab NMPA conditional approval granted for Asandeutertinib in NSCLC with CNS metastases US FDA granted Fast track designation for Varseta-M in R/R Colorectal Cancer (Ref) CytomX Therapeutics announced that the US FDA has granted Fast Track designation to Varsetatug masetecan (Varseta-M; EpCAM targeting ADC) for patient

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

18/08/2026 BH-30643 earns US FDA Fast Track designation for pretreated NSCLC FDA Endorses Registrational Path for Pelareorep in RAS‑Mutant MSS Colorectal Cancer PLN-101095 Secures US FDA Fast Track for ICI-Refractory Solid Tumors US FDA Grants Fast Track to ETX‑19477, a Novel PARG Inhibitor for BRCA‑Mutated Breast Cancer BH-30643 earns US FDA Fast Track designation for pretreated NSCLC (Ref) BlossomHill Therapeutics announced that its investigational drug BH-30643, a macrocyc

15/07/2026 Sacituzumab tirumotecan (sac-TMT) + pembrolizumab improved PFS vs chemo + pembrolizumab in PD-L1–negative NSCLC KEYTRUDA delivers first-ever PFS benefit over chemotherapy in frontline dMMR endometrial cancer Sacituzumab tirumotecan (sac-TMT) + pembrolizumab improved PFS vs chemo + pembrolizumab in PD-L1–negative NSCLC (Ref) Sichuan Kelun-Biotech announced positive Phase 3 OptiTROP-Lung06 trial results for its TROP2 ADC sacituzumab tirumotecan (sac-TMT, SKB264/MK-28

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

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

15/05/2026 FDA approved ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of neoadjuvant and adjuvant HER2+ early breast cancer UGN-103 delivers 94.5% six‑month durability in Phase 3 UTOPIA trial, with NDA submission planned for Q3 2026 to advance next‑generation RTGel therapy in recurrent LG‑IR‑NMIBC In Ph3 trial, Regeneron’s fianlimab + cemiplimab showed numeric PFS gain but missed statistical significance vs pembrolizumab in advanced or metastatic Melanoma CAN‑24

14/05/2026 Alembic secures USFDA tentative nod for Darolutamide tablets, 300 mg In Ph3 VOLGA trial, durvalumab + enfortumab vedotin significantly improved EFS and OS in MIBC Celcuity expands Phase 3 VIKTORIA-2 trial to include endocrine‑sensitive HR+/HER2‑ breast cancer patients Astellas files sNDA in Japan for PADCEV + Keytruda in cisplatin‑eligible muscle‑invasive bladder cancer, backed by Phase 3 EV‑304 survival benefit Alembic secures USFDA tentative nod for Darolutamide

08/05/2026 FDA grants RMAT designation to RZ-001, Algenomics’ RNA-based gene therapy for hepatocellular carcinoma, accelerating U.S. development and global partnership opportunities Sacituzumab tirumotecan + pembrolizumab gains NMPA priority review after landmark Phase III success in first‑line PD‑L1+ NSCLC FDA grants RMAT designation to RZ-001, Algenomics’ RNA-based gene therapy for hepatocellular carcinoma, accelerating U.S. development and global partnership opportunities

20/04/2026 Arcus halts Lung Cancer Trial With Gilead After Futility Analysis FDA granted Fast Track designation for Lunresertib + Zedoresertib in Platinum-Resistant Ovarian Cancer FDA Grants Orphan Drug Status to Orion’s ODM-212 for Mesothelioma FDA Grants Priority Review for PADCEV + Keytruda in Muscle-Invasive Bladder Cancer Arcus halts Lung Cancer Trial With Gilead After Futility Analysis (Ref) Arcus Biosciences has halted its Phase 3 lung cancer trial with Gilead Sciences

02/04/2026 Merck & Co./MSD's pembrolizumab + paclitaxel ± bevacizumab received the EC approval for Platinum-Resistant Recurrent Ovarian Carcinoma Context Therapeutics' CTIM-76 received the FDA fast track designation for platinum-resistant ovarian cancer AstraZeneca's Phase 3 EMERALD-3 trial met the PFS endpoint in embolisation-eligible unresectable HCC Merck & Co./MSD's pembrolizumab + paclitaxel ± bevacizumab received the EC approval for Platinum-Resistant Recurrent Ovarian

13/03/2026 Immutep's Phase 3 TACTI-004 trial of eftilagimod alfa regimen in 1L NSCLC NSCLC has been discontinued Immutep's Phase 3 TACTI-004 trial of eftilagimod alfa regimen in 1L NSCLC NSCLC has been discontinued (Ref) Based on the Independent Data Monitoring Committee (IDMC) recommendation, Immutep's Phase 3 TACTI-004 trial of eftilagimod alfa (LAG-3 MHC Class II agonist) + pembrolizumab + chemo regimen as a first-line treatment of NSCLC has been discontinued. Following a

18/02/2026 ImmunityBio's ANKTIVA® + BCG received conditional marketing authorization in Europe for BCG-unresponsive NMIBC CIS Johnson & Johnson's subcutaneous amivantamab received the FDA Breakthrough Therapy Designation for HPV-unrelated R/M SCCHN ImmunityBio's ANKTIVA® + BCG received conditional marketing authorization in Europe for BCG-unresponsive NMIBC CIS (Ref) The EC granted conditional marketing authorization to ImmunityBio's ANKTIVA® (nogapendekin alfa inbakicept) +

10/02/2026 Abbisko Therapeutics' irpagratinib received the FDA fast track designation for certain patients with HCC Merck's Keytruda/Keytruda Qlex regimen received FDA approval for PD-L1 positive Ovarian Cancer AstraZeneca & Daiichi's Phase 3 TROPION-Lung12 trial in stage I NSCLC has been discontinued Abbisko Therapeutics' irpagratinib received the FDA fast track designation for certain patients with HCC (Ref) The US FDA granted the fast track designation to Abbisko Therapeut

17/12/2025 Incyte's Minjuvi® received the EC approval for treatment of R/R Follicular Lymphoma J&J's RYBREVANT FASPRO™ received the FDA approval for the treatment of EGFR-mutated NSCLC pharmaand GmbH's Rubraca received the FDA full approval for the treatment of BRCA mutant mCRPC Perioperative pembro + enfortumab vedotin elicited significant benefit in MIBC Incyte's Minjuvi® received the EC approval for treatment of R/R Follicular Lymphoma (Ref) The European Commission granted

16/12/2025 Adagene's muzastotug + pembro received the FDA fast track designation for MSS mCRC without current or active liver metastases Adagene's muzastotug + pembro received the FDA fast track designation for MSS mCRC without current or active liver metastases (Ref) The US FDA granted the fast track designation (FTD) to Adagene's muzastotug (ADG126; masked anti-CTLA-4) + pembrolizumab for the treatment of adult patients with microsatellite stable metastatic colorectal cance

01/12/2025 Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia Astellas Pharma and Pfizer's Type II variation application for perioperative enfortumab vedotin + pembro has been valiated by the EMA Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia (Ref) The US FDA granted the fast track designation to Cullinan Therapeutics' CLN-049 (FLT3 x CD3 bispecific T cell engager) for th