15/09/2026 Ivonescimab significantly prolonged OS vs pembrolizumab in 1L PD-L1+ NSCLC in Chinese patients US FDA Fast Track Designation Granted for KST-6051 in Advanced Solid Tumors US FDA Accepts NDA for Bezuclastinib in Advanced Systemic Mastocytosis CSPC's EGFR ADC SYS6010 Receives NMPA Breakthrough Therapy Designation in NSCLC US FDA Accepts NDA for Bezuclastinib in Advanced Systemic Mastocytosis CSPC's EGFR ADC SYS6010 Receives NMPA Breakthrough Therapy Designation in NS

09/09/2026 US FDA grants Accelerated Approval for sevabertinib as first-line Tx in HER2-mutant NSCLC US FDA grants Accelerated Approval for sevabertinib as first-line Tx in HER2-mutant NSCLC (Ref) The US FDA has granted accelerated approval to Bayer’s sevabertinib (reversible HER2 tyrosine kinase inhibitor) as a first-line treatment for adults with locally advanced or metastatic HER2-mutant non-squamous NSCLC This decision follows Priority Review and Breakthrough Therapy Desi

07/09/2026 FDA withdraws Krazati’s colorectal cancer indication after KRYSTAL‑10 fails to confirm survival benefit FDA withdraws Krazati’s colorectal cancer indication after KRYSTAL‑10 fails to confirm survival benefit (Ref) The FDA has finalized the withdrawal of Bristol Myers Squibb’s Krazati (adagrasib; KRAS inhibitor) for colorectal cancer, citing lack of confirmed clinical benefit after the KRYSTAL‑10 Phase III trial failed to meet survival endpoints Krazati had received

26/08/2026 US FDA Fast Track designation granted for SOT106 in Soft Tissue Sarcoma; First-in-Human Trial Planned in late-2026 US FDA Fast Track designation granted for SYS6090 in MSS/pMMR metastatic colorectal cancer Celcuity submits sNDA to US FDA for approval of gedatolisib combination therapy in PIK3CA-mutant HR+/HER2- advanced breast cancer US FDA Fast Track designation granted for SOT106 in Soft Tissue Sarcoma; First-in-Human Trial Planned in late-2026 (Ref) The US FDA h

06/08/2026 US FDA Grants Accelerated Approval for Replimune’s TUDRIQEV + Nivolumab in Advanced Melanoma US FDA Grants Accelerated Approval for Replimune’s TUDRIQEV + Nivolumab in Advanced Melanoma (Ref) Replimune announced that the US FDA has granted accelerated approval for TUDRIQEV™ (vusolimogene oderparepvec-wtpg, formerly RP1; type 1 (HSV-1) oncolytic viral therapy) in combination with nivolumab for patients with unresectable advanced cutaneous Melanoma who have progresse

03/08/2026 US FDA grants Breakthrough Therapy designation to Lilly’s olomorasib for KRAS G12C-mutant pancreatic cancer FDA Grants Orphan Drug Designation to DLL3-Targeting ADC Zoci, for Neuroendocrine Carcinomas US FDA grants Breakthrough Therapy designation to Lilly’s olomorasib for KRAS G12C-mutant pancreatic cancer (Ref) Eli Lilly announced that the US FDA has granted Breakthrough Therapy designation to olomorasib (KRAS G12C inhibitor) as monotherapy for KRAS G12C-mutant a

31/07/2026 FDA grants tentative approval for OMCAZIO, a lower-dose Cabozantinib formulation with improved absorption Annamycin shows 37% CRc in Venetoclax-failed AML patients, with unblinded arms reaching up to 57% FDA grants tentative approval for OMCAZIO, a lower-dose Cabozantinib formulation with improved absorption (Ref) Handa Oncology announced that the US FDA has granted tentative approval for OMCAZIO (cabozantinib; multikinase inhibitor) capsules, a novel alternate-sal

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

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

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

22/06/2026 Exelixis’ STELLAR-303 trial showed OS benefit in ITT, non‑significant trend in NLM in mCRC; FDA decision due Dec 2026 SystImmune secures world’s first bispecific ADC approval with iza-bren in China CARsgen secures NMPA approval for satri-cel, the world’s first CAR-T therapy in solid tumors, targeting Claudin18.2-positive advanced gastric cancer Sigvotatug vedotin in metastatic non-squamous NSCLC missed OS in the overall population but showed promising efficacy in s

15/06/2026 Midstage Pancreatic Cancer Study Fails to Meet Primary Endpoint but Will Advance to Phase 3 FDA accepts ozekibart BLA, setting April 2027 PDUFA for conventional Chondrosarcoma Halia Therapeutics Secures FDA Fast Track Designation for Ofirnoflast in Lower-Risk MDS Menarini Group's Phase 3 SENTRY trial met its first co-primary endpoint, with the selinexor + ruxolitinib combination achieving significant improvement in spleen volume reduction (SVR35) vs ruxolitinib alo

02/06/2026 FDA accepts NDA and grants priority review to Roche’s giredestrant for early-stage ER+, HER2- breast cancer Candel’s CAN‑2409 Phase 3 in localized prostate cancer shows significant DFS benefit with favorable safety, supporting BLA filing in Q4 2026 Cycle Pharma secures FDA approval for CAVHANZA™, the first nilotinib ODT eliminating PPI/H₂RA timing restrictions to broaden Ph+ CML treatment flexibility FDA accepts NDA and grants priority review to Roche’s giredestran

01/06/2026 FDA grants Fast Track to Nouscom’s NOUS‑209, advancing the immunotherapy aimed at intercepting Lynch Syndrome‑associated cancers FDA grants Fast Track to Nouscom’s NOUS‑209, advancing the immunotherapy aimed at intercepting Lynch Syndrome‑associated cancers (Ref) NOUS‑209, an off‑the‑shelf cancer immunotherapy, received Fast Track status for preventing Lynch Syndrome (LS)‑associated cancers in carriers with mismatch repair mutations Phase 1b/2 data showed NOUS‑209

31/05/2026 Johnson & Johnson submits US sBLA for subcutaneous amivantamab in HPV-unrelated R/M HNSCC, previously treated with immunotherapy and chemotherapy Johnson & Johnson submits US sBLA for subcutaneous amivantamab in HPV-unrelated R/M HNSCC, previously treated with immunotherapy and chemotherapy (Ref) Johnson & Johnson confirmed that a supplemental Biologics License Application (sBLA) has been submitted to the US FDA seeking approval of subcutaneous amivantamab (EGFR x

19/05/2026 Cullinan’s CLN‑049 earns FDA Orphan Drug Designation in relapsed/refractory AML FL118 Receives Dual FDA Designations for Osteosarcoma, Advancing Rare Pediatric Cancer Treatment Cullinan’s CLN‑049 earns FDA Orphan Drug Designation in relapsed/refractory AML (Ref) LN-049, a novel FLT3 x CD3 T cell engager, has received Orphan Drug Designation for relapsed/refractory acute myeloid leukemia (AML) CLN-049 is in Phase 1 trials, including multiple ascending dose studies i

13/05/2026 FDA grants Fast Track to SUPLEXA, advancing Alloplex’s non-engineered immune cell therapy for MSI-H colorectal cancer FDA grants Fast Track to SUPLEXA, advancing Alloplex’s non-engineered immune cell therapy for MSI-H colorectal cancer (Ref) The FDA has granted Fast Track Designation to SUPLEXA for treating colorectal cancer patients with the MSI-H phenotype Alloplex has submitted its US IND package for SUPLEXA in CRC-MSI-H and is advancing preparatory clinical act

12/05/2026 FDA grants Breakthrough Therapy Designation to Servier’s B7‑H4 ADC Emiltatug Ledadotin (Emi‑Le) for advanced adenoid cystic carcinoma Rigel secures global rights to VEPPANU, the first FDA‑approved oral PROTAC, with strong Phase 3 data in ER+/HER2‑, ESR1‑mutated breast cancer ZUSDURI delivers 64.5% 3‑year event‑free durability in recurrent LG‑IR‑NMIBC FDA grants Breakthrough Therapy Designation to Servier’s B7‑H4 ADC Emiltatug Ledadotin (Emi‑Le) for advanced adenoid

11/05/2026 FDA grants Fast Track to Zai Lab’s DLL3‑targeting ADC Zocilurtatug Pelitecan (Zoci) for epNECs Hansoh Pharma’s HS-20093 B7-H3 ADC wins NMPA Breakthrough Therapy nod in ESCC Innovent’s IBI363 secures third Breakthrough Therapy Designation in China, advancing to Phase III for MSS/pMMR colorectal cancer with Takeda partnership FDA grants Fast Track to Zai Lab’s DLL3‑targeting ADC Zocilurtatug Pelitecan (Zoci) for epNECs (Ref) Zai Lab's : Zocilurtatug pelitecan (Zoci,

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