11/10/2026 EMA validates aumolertinib MAA, initiating EU review in EGFR-mutated NSCLC EMA validates aumolertinib MAA, initiating EU review in EGFR-mutated NSCLC (Ref) Hansoh announced resubmission of the EU Marketing Authorization Application (MAA) for aumolertinib (EGFR-TKI) to the European Medicines The EMA validated the application on October 7, 2026 and the centralized regulatory review process has officially begun The application seeks approval for two EGFR-mutated NSCLC

07/10/2026 US FDA grants two breakthrough therapy designations to AbbVie’s c-Met ADC Temab-A in CRC and NSCLC US FDA approves tucatinib-based maintenance regimen for HER2-positive Breast Cancer US FDA grants two breakthrough therapy designations to AbbVie’s c-Met ADC Temab-A in CRC and NSCLC (Ref) AbbVie announced that the US FDA has granted two Breakthrough Therapy Designations (BTDs) to c-Met-targeted antibody-drug conjugate (ADC), telisotuzumab adizutecan (Temab-A/ABBV-400

06/10/2026 Firmonertinib failed to demonstrate statistically significant PFS benefit in 1L EGFR Exon 20ins NSCLC Firmonertinib failed to demonstrate statistically significant PFS benefit in 1L EGFR Exon 20ins NSCLC (Ref) ArriVent announced a program update from the Phase 3 FURVENT trial evaluating firmonertinib (EGFR-TKI) as first-line treatment for patients with EGFR exon 20 insertion-mutant NSCLC. While the study did not meet its primary endpoint of progression-free surviva

01/10/2026 Cullinan Initiates NDA Submission for Zipalertinib + Chemotherapy in 1L EGFR Exon 20ins NSCLC Trethera receives FDA Fast Track Designation for TRE-515 combination strategy in KRAS G12C-Mutant NSCLC Replimune announces US launch of TUDRIQEV™ for advanced Melanoma Cullinan Initiates NDA Submission for Zipalertinib + Chemotherapy in 1L EGFR Exon 20ins NSCLC (Ref) Cullinan Therapeutics announced the initiation of a US FDA New Drug Application (NDA) submission under the

29/09/2026 Plinabulin secures US FDA Fast Track Designation as BeyondSpring advances Phase 3 DUBLIN-4 NSCLC program with strategic China funding agreement HUTCHMED announces US NDA Submission for ORPATHYS + TAGRISSO in MET-Driven EGFR-Mutated NSCLC US FDA grants Orphan Drug and Rare Pediatric Disease designations to UTR Therapeutics' MYCN-targeting candidate UTRxMYCN M1-14 Plinabulin secures US FDA Fast Track Designation as BeyondSpring advances Phase 3 DUBLIN-4 NSCLC program

28/09/2026 Evorpacept demonstrates efficacy benefit in HER2-retained/high-CD47 gastric cancer subsets, in Phase 2 ASPEN-06 study; ALX will not pursue a US registrational Phase 3 study, evaluates partnership opportunities Innovent expands Phase 3 MarsLight-11 trial of IBI363/TAK-928 in NSCLC AstraZeneca invests $2B in Summit Therapeutics to advance ivonescimab-ADC combination strategy across multiple cancers Teva Receives US FDA Approval for DEGEVMA, a biosimilar to Xgeva (den

24/09/2026 US FDA approves belzutifan + lenvatinib in post-IO advanced ccRCC based on PFS superiority over cabozantinib, despite no statistically significant OS benefit CSPC reports positive Phase III results for becotatug + osimertinib, demonstrating significant PFS benefit and favorable OS trend in first-Line EGFR Exon20ins NSCLC US FDA approves belzutifan + lenvatinib in post-IO advanced ccRCC based on PFS superiority over cabozantinib, despite no statistically significant

17/09/2026 Phase III CELESTIMO study met its primary endpoint of PFS, with Lunsumio + lenalidomid in Follicular Lymphoma OS Therapies announces FDA Alignment on Phase 3 Design and Project Orbis Participation for OST-HER2 in metastatic osteosarcoma US FDA Approves Label Update for IBTROZI (taletrectinib), with Updated Duration of Response in TKI-Naïve Advanced ROS1-Positive NSCLC NICE Recommends Enhertu for HER2-Low Advanced Breast Cancer Phase III CELESTIMO study met its prim

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

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

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

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

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