09/04/2026 NMPA Accepts NDA for DB-1303/BNT323 in HER2+ Metastatic Breast Cancer Celltrion Wins Dual FDA Fast Track Approvals for ADC Pipeline Satri-cel: First CAR-T Therapy for Solid Tumors Set to Launch in China NMPA Accepts NDA for DB-1303/BNT323 in HER2+ Metastatic Breast Cancer ( Ref ) The New Drug Application (NDA) for DualityBio and BioNTech's DB-1303/BNT323 (Trastuzumab Pamirtecan, T-Pam; HER2‑targeted ADC) has been accepted by China’s National Medical Products Admini

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), i

March 3rd Week, 2026 Regulatory Events 🎯 The US FDA approved Bristol Myers Squibb 's nivolumab (anti-PD-1) + doxorubicin + vinblastine + dacarbazine for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III/IV cHL. Additionally, the EC approved nivolumab + brentuximab vedotin for the treatment of children 5 years of age and older, adolescents, and adults up to 30 years of age with R/R cHL after one prior line of therapy. (Ref

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 pati

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 appro

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 ap

17/03/2026 CRISM Therapeutics' irinotecan received the FDA ODD for malignant glioma Voro Therapeutics and Daiichi Sankyo sign a research collaboration for Next-Generation Tumor-Activated ADCs Myriad Genetics' MyChoice CDx test received FDA approval as the companion diagnostic for Zejula CRISM Therapeutics' irinotecan received the FDA ODD for malignant glioma ( Ref ) The US FDA granted the Orphan Drug Designation to CRISM Therapeutics Corporation's irinotecan for the treatment

February 1st Week, 2026 Regulatory Events 🎯 The US FDA approved an update to Gilead Sciences ' axicabtagene ciloleucel (anti-CD19 CAR-T) prescribing information removing the previous “Limitations of Use” in patients with relapsed/refractory primary central nervous system lymphoma (Ref 1) ❓ How would this decision alter Yescarta’s positioning in the market landscape? 🎯 AstraZeneca and Daiichi Sankyo US ’ sBLA for datopotamab deruxtecan (TROP2 ADC) was accepted and grante

03/02/2026 Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer The US FDA granted priority review status to Datroway for the treatment of TNBC Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer ( Ref ) The US FDA granted the breakthrough therapy designation to Relay Therapeutics' zovegalisib (PI3Kα inhibitor) + fulvestrant for the treatment of adults wi

20/01/2026 In the Ph2b KN-942 trial, Moderna and Merck's intismeran autogene + pembro showed sustained RFS benefit at 5 years of median follow-up Lilly's sofetabart mipitecan received the FDA Breakthrough Therapy designation for platinum-resistant ovarian cancer Celcuity's NDA for gedatolisib has been accepted for priority review for advanced breast cancer Lantern Pharma's LP-284 received the FDA orphan drug designation for soft tissue sarcomas In the Ph2b KN-942 trial, Moder

07/01/2026 Arbele's ARB1002 received the FDA orphan drug designation for pancreatic cancer Curadel Pharma's CPI-008 imaging drug received the FDA and EMA orphan drug designation for pancreatic cancer Arbele's ARB1002 received the FDA orphan drug designation for pancreatic cancer ( Ref ) The US FDA granted the orphan drug designation to Arbele's ARB1002 (CDH17 targeting ADC) for the treatment of pancreatic cancer. Dr Linda Wu, CDO, Arbele: " Orphan Drug Designation for ARB10

December 4th Week, 2025 Regulatory Events 🎯 The US FDA granted accelerated approval to Roche 's Lunsumio VELO (mosunetuzumab; CD20 x CD3 BsAb), as a subcutaneous formulation, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. (Ref 1) ❓ What are the key pros and cons of this subcutaneous therapy? Clinical Events 🔬 The Phase 3 LATIFY trial of AstraZeneca 's ceralasertib (ATR kinase inhibitor) +

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

December 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted approval to Johnson & Johnson Innovative Medicine 's sNDA for niraparib and abiraterone acetate dual-action tablet (PARB inhibition and novel hormonal therapy) + prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? Clinical Events 🔬 The Phase 3 STAR-221 trial o

November 4th Week, 2025 Regulatory Events 🎯 The EC granted approval to Bristol Myers Squibb 's lisocabtagene maraleucel (anti-CD19 CAR-T) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy including a BTK inhibitor. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? 🎯 The US FDA granted approval to AstraZeneca ’s neoadjuvant durvalumab (anti-PD-L1) + ch

01/12/2025 Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia Astellas Pharma and Pfizer's Type II variation application for perioperative enfortumab vedotin + pembro has been valiated by the EMA Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia ( Ref ) The US FDA granted the fast track designation to Cullinan Therapeutics' CLN-049 (FLT3 x CD3 bispecific T cell engager) for

November 3rd Week, 2025 Regulatory Events 🎯 The EC granted approval to Merck & Co./ MSD 's subcutaneous formulation of pembrolizumab (KEYTRUDA SC, anti-PD-1) for use across all 33 KEYTRUDA indications for adult patients in Europe. (Ref 1) ❓ What are the key pros and cons of this SC formulation? 🎯 The EC granted approval to Regeneron 's cemiplimab (anti-PD-1) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after

November 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted full approval to Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. 's ziftomenib (menin inhibitor) for adult patients with R/R AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. (Ref 1) ❓ How is this approval expected to impact the Tx algorithm of AML? Clinical Events 🔬 In the Phase 3 PEAK trial, Cogent Biosciences ' bezuclastinib (KIT inhibitor) + sunitinib met the prim

November 1st Week, 2025 Regulatory Events 🎯 The US FDA approved Johnson & Johnson 's Darzalex Faspro (daratumumab, an anti-CD38, and hyaluronidase) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of this indication? Clinical Events 🔬 In the registrational cohort of the Phase 2 IOV-LUN-202/NCT04614103 trial, Iovance Biotherapeutics, Inc. ’s lifileuc

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 t