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

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

26/02/2026 Boehringer Ingelheim's zongertinib received accelerated approval for HER2m NSCLC Izalontamab brengitecan elicited significant PFS and OS benefit in TNBC Boehringer Ingelheim's zongertinib received accelerated approval for HER2m NSCLC (Ref) The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (kinase inhibitor) for an expanded indication for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 TKD activating mutat

23/02/2026 Artios Pharma's ART6043 + olaparib received the FDA fast track designation for breast cancer RYBREVANT SC received EC approval for Q3W and Q4W dosing for EGFR-mutated NSCLC Artios Pharma's ART6043 + olaparib received the FDA fast track designation for breast cancer (Ref) The US FDA granted the Fast Track designation to Artios Pharma's ART6043 (DNA polymerase theta (Polθ) inhibitor) + olaparib (PARP inhibitor) for the treatment of adult patients with germline BRCA-m

17/02/2026 Deciphera Pharmaceuticals' NDA for tirabrutinib has been accepted by the US FDA for R/R PCNSL J&J's RYBREVANT FASPRO™ received FDA approval for once a month dosing schedule for EGFRm NSCLC BMS' NDA for iberdomide + standard treatment has been accepted by the US FDA for R/R MM Deciphera Pharmaceuticals' NDA for tirabrutinib has been accepted by the US FDA for R/R PCNSL (Ref) The US FDA has accepted for filing the NDA under the accelerated approval pathway for Deciph

16/02/2026 Phase 3 LIBRETTO-432 trial of adjuvant selpercatinib met the EFS endpoint in RET fusion positive NSCLC Phase 3 LIBRETTO-432 trial of adjuvant selpercatinib met the EFS endpoint in RET fusion positive NSCLC (Ref) Eli Lilly and Company announced positive topline results from the Phase 3 LIBRETTO-432 clinical trial of selpercatinib (Retevmo; RET kinase inhibitor) as an adjuvant therapy versus placebo in patients with early-stage (II-IIIA) RET fusion-positive NSCLC. Th

09/02/2026 Krystal Biotech's KB707 received the FDA RMAT Designation for advanced or metastatic NSCLC Krystal Biotech's KB707 received the FDA RMAT Designation for advanced or metastatic NSCLC (Ref) The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Krystal Biotec's KB707 (redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 and interleukin-12 in the tumor microenvironment) for the treatment of advanced or

29/01/2026 Quetzal Therapeutics' QTX-2101 received the FDA Fast Track designation for acute promyelocytic leukemia Summit's BLA for ivonescimab + chemo accepted by the FDA for EGFRm NSCLC The Phase III IMpower030 trial of perioperative atezolizumab + chemo failed to meet EFS endpoint in NSCLC Quetzal Therapeutics' QTX-2101 received the FDA Fast Track designation for acute promyelocytic leukemia (Ref) The US FDA granted the Fast Track designation to Quetzal Therapeutics' QTX-2