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

August 3rd Week, 2026 Special Designations ⭐ The US FDA granted a Fast Track Designation to 858 Therapeutics' ETX-19477 (PARG inhibitor) for the Tx of adults with BRCA‑mutated, HR+/HER2‑ unresectable or metastatic breast cancer (Ref1) ❓ Who are the key competitors to ETX-19477 in the BRCA-m HR+/HER- BC? ⭐ The US FDA granted FTD to BlossomHill Therapeutics, Inc.’s BH-30643 (macrocyclic OMNI-EGFR™ inhibitor) for the Tx of adults with advanced or metastatic EGFR C797S-posit

August 2nd Week, 2026 Regulatory Events 🎯 The US FDA granted a Type C Statistical Methods Meeting to OS Therapies to review the 2.5yrs OS data from the Ph2b trial of daznelimgene lisbac (OST-HER2; HER2 targeted immunotherapy vaccine) in the prevention of recurrence in fully resected, pulmonary metastatic osteosarcoma (Ref) ❓ How is OST-HER2 positioned in the osteosarcoma developmental landscape? Special Designations ⭐ The US FDA granted a Fast Track Designation to Gran

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

17/08/2026 Enhertu delivers first-ever PFS benefit in 1L HER2-mutant NSCLC AstraZeneca halts Phase 3 eVOLVE-Lung02 trial of volrustomig in mNSCLC ORPATHYS + TAGRISSO deliver survival benefit in MET-driven EGFRm NSCLC US FDA fast track designation granted for PIKTOR + paclitaxel in biomarker-selected advanced Endometrial Cancer UroGen submits NDA for UGN-103 in recurrent LG-IR-NMIBC Enhertu delivers first-ever PFS benefit in 1L HER2-mutant NSCLC (Ref) AstraZeneca and Daiichi S

12/08/2026 NMPA approves ivonescimab + chemo for first‑line advanced squamous NSCLC Zipalertinib Combo Achieves PFS Milestone in EGFR Exon 20 NSCLC, FDA Filing Planned NMPA approves ivonescimab + chemo for first‑line advanced squamous NSCLC (Ref) China’s NMPA approved Akeso Bio & Summit Therapeutics' ivonescimab (PD-1 x VEGF) in combination with chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC) The approval was based on the signi

July 4th Week, 2026 Regulatory Events 🎯 GSK's zidesamtinib (Jideytro; ROS1 selective inhibitor) was approved by the US FDA for the Tx of adults with LA/M ROS1-positive NSCLC who have previously received a ROS1 kinase inhibitor (Ref) ❓ How is GSK positioned in the ROS1 NSCLC market landscape? 🎯 The US FDA has granted Priority Review for a supplemental NDA of Pfizer’s talazoparib (TALZENNA; PARP inhibitor) + Pfizer and Astellas Pharma's enzalutamide (XTANDI; androgen recep

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

21/07/2026 Toripalimab + chemo gains NMPA acceptance as perioperative NSCLC therapy, cutting recurrence risk by 60% Toripalimab + chemo gains NMPA acceptance as perioperative NSCLC therapy, cutting recurrence risk by 60% (Ref) The National Medical Products Administration (NMPA) has accepted Junshi Biosciences’ supplemental application for toripalimab + platinum chemotherapy as perioperative treatment (plus adjuvant monotherapy) for resectable stage II–III NSCLC patients The s

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

14/07/2026 FDA frants Fast Track Designation to SOTIO’s SOT109 (CDH17-targeting) ADC for advanced Colorectal Cancer FDA grants full approval to selpercatinib for RET fusion positive solid tumors AstraZeneca secures global rights to Zegfrovy, first oral EGFR exon 20 NSCLC therapy, in $600M upfront deal with Dizal In a Ph3 trial, HBI-8000 + nivolumab improved PFS vs nivolumab + placebo, for advanced Melanoma FDA approved first generics of Gilotrif (afatinib) for EGFR‑mutant and

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

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

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

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

June 1st Week, 2026 Regulatory Updates 🎯 Australia’s Therapeutic Goods Administration (TGA) has conditionally approved Iovance Biotherapeutics, Inc.'s lifileucel (Amtagvi®; tumor infiltrating lymphocytes), making it the first T cell therapy for a solid tumor and the first treatment option in Australia for advanced melanoma in adults, after anti‑PD‑1 and targeted therapy (Ref) ❓ Which other regimens have the potential to challenge lifileucel in this setting? 🎯 The U

08/06/2026 Zai Lab secures China NMPA approval for TIVDAK®, the first ADC for recurrent/metastatic cervical cancer Merck & Gilead halt Phase 3 KEYNOTE-D46/EVOKE-03 trial as Trodelvy + Keytruda fails to show statistically significant survival benefit in first-line PD-L1–high NSCLC Zai Lab secures China NMPA approval for TIVDAK®, the first ADC for recurrent/metastatic cervical cancer (Ref) China’s NMPA approved TIVDAK® (tisotumab vedotin) for adult patients with recurrent or me

03/06/2026 Terremoto Biosciences Secures FDA Fast Track for AKT1‑Selective Inhibitor TER‑2013 in HR+/HER2– Breast Cancer FDA grants Orphan Drug Designation to Sotio’s LRRC15-targeted ADC SOT106 for osteosarcoma, advancing toward first-in-human trial in 2H26 Lupin & Natco secure FDA approval for Eribulin generic, unlocking $43.7M U.S. market opportunity Verastem’s VS-7375 secures FDA Fast Track for KRAS G12D-mutated NSCLC Amtagvi® (lifileucel) wins conditional TGA approval as

May 3rd Week, 2026 Regulatory Events 🎯 Shanghai Junshi Biosciences Co Ltd’s NDA for toripalimab (anti-PD-1) + RemeGen Biosciences’ disitamab vedotin (HER2 ADC) for patients with HER2-expressing LA/M urothelial carcinoma was approved by the NMPA. (Ref 1) ❓ What are the clinical outcomes that support this approval? Special Designations ⭐ The US FDA granted the Priority Review status to Bayer’s sevabertinib (HER2 TKI) for the first-line treatment of adult patients with LA/M

18/05/2026 Sacituzumab tirumotecan (Sac‑TMT) delivers survival benefit in advanced endometrial cancer, meeting OS and PFS endpoints over chemotherapy FDA grants Priority Review to Bayer’s HYRNUO® (sevabertinib) for first-line treatment of HER2-mutated NSCLC Sacituzumab tirumotecan (Sac‑TMT) delivers survival benefit in advanced endometrial cancer, meeting OS and PFS endpoints over chemotherapy (Ref) The Phase 3 TroFuse-005 study of sacituzumab tirumotecan (Sac‑TMT), a TROP2-d