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

31/08/2026 MT027 secures US FDA Fast Track designation for recurrent Glioblastoma FDA clears IDEAYA’s IDE849 Phase 3 path in ES-SCLC In Phase 3 HERIZON-GEA-01 trial, ZIIHERA + chemotherapy demonstrated a statistically significant improvement in OS vs trastuzumab + chemotherapy, meeting the primary endpoint ORPATHYS + TAGRISSO® demonstrated significant PFS benefit with early OS signal in first-line EGFRm NSCLC with MET overexpression Karyopharm files sNDA for selinexor + ruxol

25/08/2026 US FDA approves zanidatamab combination therapy in HER2+ GEA US FDA approves zanidatamab combination therapy in HER2+ GEA (Ref) The US FDA has approved Jazz, BeOne and Zymeworks' Ziihera (zanidatamab-hrii; bispecific HER2-directed antibody) with and without BeOne's tislelizumab (anti-PD-1) + chemotherapy for first-line treatment of HER2+ advanced gastroesophageal adenocarcinoma (GEA), regardless of PD-L1 status Approval was supported by Phase 3 HERIZON-GEA-01 trial

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

21/05/2026 Junshi Biosciences secures NMPA approval for toripalimab + disitamab vedotin in HER2+ urothelial carcinoma Kelun-Biotech's Phase III sac-TMT Trial meets Primary PFS Endpoint in First-Line Advanced TNBC Junshi Biosciences secures NMPA approval for toripalimab + disitamab vedotin in HER2+ urothelial carcinoma (Ref) China’s NMPA approved toripalimab + disitamab vedotin for first-line treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma (UC)

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

March 4th Week, 2026 Regulatory Events 🎯 The US FDA granted approval to Corcept Therapeutics Incorporated's relacorilant (selective glucocorticoid receptor antagonist) + nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. (Ref 1) ❓ What are the clinical outcomes that support this approval

23/03/2026 AstraZeneca & Daiichi Sankyo's ENHERTU received approval in Japan for HER2+ solid cancers AstraZeneca & Daiichi Sankyo's ENHERTU received approval in Japan for HER2+ solid cancers (Ref) Japan’s Ministry of Health, Labour and Welfare (MHLW) granted approval to AstraZeneca & Daiichi Sankyo's ENHERTU® (trastuzumab deruxtecan) for the treatment of adult patients with HER2+, advanced or recurrent solid cancers refractory or intolerant to standard treatments. The approva

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

05/02/2026 Partner Therapeutics' zenocutuzumab received the FDA orphan drug designation for cholangiocarcinoma Partner Therapeutics' zenocutuzumab received the FDA orphan drug designation for cholangiocarcinoma (Ref) The US FDA granted the orphan drug designation to Partner Therapeutics' zenocutuzumab‑zbco (HER2xHER3 bispecific antibody) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma. Zenocutuzumab is being developed in a subset of pa

02/02/2026 OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma Exelixis' NDA for zanzalintinib + atezolizumab in mCRC has been accepted for review by the US FDA TuHURA Biosciences' IFx-2.0 received the FDA orphan drug designation for cutaneous Melanoma OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma (Ref) OS Therapies has initiated a BLA submission to the US FDA for OST-HER2 (HER2-bioengineered form of Listeria monocytogenes) in the p

20/12/2025 Alphamab & CSPC's JSKN003 ADC received the FDA Breakthrough Therapy Designation for the Treatment of PROC Alphamab & CSPC's JSKN003 ADC received the FDA Breakthrough Therapy Designation for the Treatment of PROC (Ref) The US FDA granted the breakthrough therapy designation to Alphamab Oncology and CSPC Pharma's JSKN003 (biparatopic HER2-targeting ADC) for the treatment of adult patients with advanced or metastatic platinum-resistant recurrent epithelial ovarian ca

10/11/2025 Boehringer Ingelheim's zongertinib received the Commissioner’s National Priority Voucher for HER2-mutant NSCLC (Ref) The US FDA awarded a Commissioner’s National Priority Voucher (CNPV) to Boehringer Ingelheim's zongertinib (HER2 TKI) for the treatment of patients with HER2-mutant NSCLC. Boehringer Ingelheim is planning a sNDA for zongertinib in the first-line treatment of patients with HER2-mutant NSCLC Previously, zongertinib received accelerated approval by the

28/10/2025 Alphamab Oncology's JSKN003 received the FDA fast track designation for PROC (Ref) The US FDA granted the fast track designation to Alphamab Oncology's JSKN003 (biparatopic HER2-targeting antibody-drug conjugate) for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC). To note, in Sep'24, Alphamab entered a licensing agreement with JMT-Bio Technology (a wholly-ow

29/09/2025 In an ~$8B deal, Genmab will acquire Merus in an all-cash transaction (Ref) Genmab and Merus announced a transaction agreement pursuant to which Genmab will acquire all the shares of Merus for $97.00 per share in an all-cash transaction representing a transaction value of ~$8.0 billion. The transaction has been unanimously approved by the Boards of Directors of both companies A wholly owned subsidiary of Genmab will commence a tender offer for 100% of Merus’ common

24/09/2025 AstraZeneca and Daiichi's trastuzumab deruxtecan + pertuzumab received priority review status for first-line HER2+ve breast cancer (Ref) The US FDA accepted and granted Priority Review to AstraZeneca and Daiichi Sankyo’s sBLA for trastuzumab deruxtecan (Enhertu; HER2 ADC) + pertuzumab for the first-line Tx of adult patients with unresectable or metastatic HER2-positive breast cancer. The PDUFA date is anticipated during Q1'26 The sBLA was based on results from th

05/09/2025 CERo Therapeutics' CER-1236 received the FDA Fast Track Designation for AML (Ref) The US FDA granted the Fast Track Designation to CERo Therapeutics' CER-1236 (TIM-4 ligand targeting CER-T therapy) for the treatment of Acute Myeloid Leukemia (AML). Chris Ehrlich, CEO, CERo Therapeutics: “These FDA designations are important additional validation with regard to the urgency of the condition as well as the potential that the agency sees in the existing data as submitt

14/07/2025 Henlius’ Ph3 trial of HLX22 combo has dosed the first HER2+ GC patient in the US (Ref) Shanghai Henlius Biotech announced the dosing of the first patient in the US in Phase 3 HLX22-GC-301 international, multicentre trial of HLX22 (anti-HER2) + trastuzumab + chemotherapy vs trastuzumab + chemotherapy ± pembrolizumab as a first-line Tx for HER2+ve, locally advanced or metastatic gastroesophageal junction cancer and gastric cancer The primary endpoints of this study a

March 3rd Week, 2025 Regulatory Events 🎯 The US FDA granted traditional approval to Merck & Co./MSD’s pembrolizumab (anti-PD-1) + trastuzumab (anti-HER2) + fluoropyrimidine- and platinum-containing chemo for the first-line treatment of adults with locally advanced, unresectable/metastatic HER2+ve gastric/gastroesophageal junction adenocarcinoma with PD-L1 CPS ≥1 (Ref 1). The regimen was previously granted accelerated approval for this indication in May’21. ❓ Which other re