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

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

September 3rd Week, 2026 Regulatory Events 🎯 AstraZeneca’s sBLA for perioperative durvalumab (Imfinzi; anti-PD-L1) + Astellas Pharma and Pfizer’s neoadjuvant enfortumab vedotin (Padcev; Nectin-4 ADC) was accepted and granted Priority Review by the US FDA for the Tx of MIBC patients who are ineligible/have declined cisplatin-based chemotherapy (Ref1) ❓ What are the current efficacy benchmarks for perioperative MIBC? 🎯 The US FDA approved Merck&Co/MSD's belzutifan (Welir

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

September 2nd Week, 2026 Regulatory Events 🎯 The US FDA granted Accelerated Approval to Bayer’s sevabertinib (HYRNUO; mutant HER2 TKI) for the 1L Tx of HER2-mutant nsq-NSCLC with HER2/ERBB2 tyrosine kinase domain activating mutations (Ref1) ❓ How is sevabertinib positioned in NSCLC Tx landscape? 🎯 The US FDA extended the review period for Exelixis' zanzalintinib (multi-TKI) + Roche's atezolizumab (Tecentriq; anti-PD-L1) NDA for pretreated MSS CRC by 3 months, resulting i

September 1st Week, 2026 Regulatory Events 🎯 The US FDA granted an accelerated approval to AstraZeneca's camizestrant (Etcamah; SERD and complete ER antagonist) + a CDK4/6 inhibitor for the 1L Tx of HR+/HER2- ESR1-mutated LA/M breast cancer (Ref1) ❓ What is the addressable market size for Etcamah in the US? 🎯 AstraZeneca and Daiichi Sankyo' trastuzumab deruxtecan (Enhertu; HER2 ADC) + pertuzumab (anti-HER2) has secured EU approval as 1L Tx for HER2+ unresectable or met

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

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

July 2nd Week, 2026 Special Designation ⭐ PRG S&Tech Inc.’s Trineumin (small-molecule modulator of the abnormal TβR1-RKIP interaction (caused by NF2 gene mutation)) has been granted the Rare Pediatric Disease Designation (RPDD) by the US FDA for the Tx of Neurofibromatosis Type 2 (NF2) (Ref) ❓ What is the addressable market for NF2 in the US? ⭐ CSPC Pharmaceutical Group's SYS6043 (B7-H3 ADC) received the Breakthrough Therapy Designation from China’s NMPA for the Tx of plati

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

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

28/04/2026 FDA accepts NDA for zipalertinib in EGFR exon 20–mutated NSCLC; PDUFA set for Feb 2027 FDA Grants RMAT Designation to Orca-Q, Advancing Precision Cell Therapy for High-Risk Hematologic Malignancies Scancell’s iSCIB1+ secures FDA Fast Track with 77% PFS, Phase 3 initiation anticipated in H2 2026 for advanced Melanoma Henlius secures EU approval for POHERDY® (pertuzumab biosimilar), expanding global oncology footprint FDA accepts NDA for zipalertinib in EGFR exon 20–

07/04/2026 Corbus Gains FDA Alignment on CRB‑701 Registrational Trials in HNSCC and Cervical Cancer Nuvalent Submits NDA for Neladalkib in ALK+ NSCLC NextCure Receives Fast Track Designation for SIM0505 (CDH6 ADC) in Ovarian Cancer Corbus Gains FDA Alignment on CRB‑701 Registrational Trials in HNSCC and Cervical Cancer (Ref) Corbus reached broad agreement with the FDA on the registration path for CRB-701, a next-generation Nectin-4 targeting antibody-drug conjugate (ADC), in

30/03/2026 Zymeworks' ZW191 ADC received the FDA fast track designation for PROC Elevar Therapeutics' NDA for lirafugratinib received priority review status from the FDA for cholangiocarcinoma Henlius Biotech's serplulimab + chemo received positive CHMP opinion for NSCLC and ESCC Zymeworks' ZW191 ADC received the FDA fast track designation for PROC (Ref) The US FDA granted the fast track designation to Zymeworks Inc's ZW191 (FRα-targeting ADC) for the treatment of patients

25/03/2026 Corcept's relacorilant + nab-paclitaxel received FDA approval for platinum-resistant Ovarian Cancer TRIANA Biomedicines' TRI-611 received the FDA fast track designation for ALK+ NSCLC In a $6.7B deal, Merck & Co acquired Terns Pharmaceuticals to expand its hematology pipeline Corcept's relacorilant + nab-paclitaxel received FDA approval for platinum-resistant Ovarian Cancer (Ref) The US FDA granted approval to Corcept Therapeutics Incorporated's Lifyorli (relacori

21/03/2026 Dizal's Phase 3 WU-KONG28 trial of ZEGFROVY met its PFS endpoint as a first-line treatment of EGFRexon20ins NSCLC Dizal's Phase 3 WU-KONG28 trial of ZEGFROVY met its PFS endpoint as a first-line treatment of EGFRexon20ins NSCLC (Ref) The multinational Phase 3 WU-KONG28 trial evaluating Dizal's ZEGFROVY® (sunvozertinib) monotherapy as first-line treatment in NSCLC with EGFR exon20ins met its primary endpoint of PFS. The WU-KONG28 study evaluated ZEGFROVY versus plat

March 2nd Week, 2026 Regulatory Events 🎯 The EC has approved an indication extension for Johnson & Johnson Innovative Medicine's AKEEGA® (niraparib and abiraterone acetate dual action tablet) with prednisone or prednisolone in combination with androgen deprivation therapy, for the treatment of patients with metastatic hormone-sensitive prostate cancer and BRCA1/2 mutations (germline and/or somatic). (Ref 1) ❓ How do the outcomes of this regimen compare against the other appr