24/03/2026 The Ph3 SENTRY trial of Karyopharm's selinexor + ruxolitinib met SVR35 but not Abs-TSS endpoint in frontline myelofibrosis ReCerise's RCT1213 received the FDA ODD for hepatocellular carcinoma The Ph3 SENTRY trial of Karyopharm's selinexor + ruxolitinib met SVR35 but not Abs-TSS endpoint in frontline myelofibrosis (Ref) Karyopharm Therapeutics reported topline results from its Phase 3 SENTRY trial of selinexor 60 mg + ruxolitinib in frontline myelofibrosis. The tria

10/02/2026 Abbisko Therapeutics' irpagratinib received the FDA fast track designation for certain patients with HCC Merck's Keytruda/Keytruda Qlex regimen received FDA approval for PD-L1 positive Ovarian Cancer AstraZeneca & Daiichi's Phase 3 TROPION-Lung12 trial in stage I NSCLC has been discontinued Abbisko Therapeutics' irpagratinib received the FDA fast track designation for certain patients with HCC (Ref) The US FDA granted the fast track designation to Abbisko Therapeut

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

27/01/2026 Johnson & Johnson's DARZALEX FASPRO regimen has been approved in the US for multiple myeloma Imviva Biotech's CTD402 CAR-T received the FDA orphan drug designation for T-ALL/LBL Nanjing Leads Biolabs' LBL-034 received the FDA fast track designation for multiple myeloma Johnson & Johnson's DARZALEX FASPRO regimen has been approved in the US for multiple myeloma (Ref) The US FDA granted approval to Johnson & Johnson's DARZALEX FASPRO (daratumumab and hyaluronidase-fi

14/01/2026 Nanjing Leads Biolabs' opamtistomig received the FDA fast track designation for extra-pulmonary neuroendocrine carcinoma Nanjing Leads Biolabs' opamtistomig received the FDA fast track designation for extra-pulmonary neuroendocrine carcinoma (Ref) The US FDA granted fast track designation to Nanjing Leads Biolabs' opamtistomig (LBL-024; PD-L1 x 4-1BB bispecific antibody) for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC). Dr. Charles Cai, CMO,

10/12/2025 GSK's risvutatug rezetecan received the FDA orphan drug designation for SCLC Ajax Therapeutics' AJ1-11095 received the FDA orphan drug designation for myelofibrosis GSK's risvutatug rezetecan received the FDA orphan drug designation for SCLC (Ref) The US FDA granted the orphan drug designation to GSK's risvutatug rezetecan (B7-H3-targeted ADC) for the treatment of small-cell lung cancer (SCLC). The ODD was based on preliminary clinical data of the Phase 1 ARTEMIS-0

08/12/2025 Chimeric Therapeutics' CHM CDH17 received the FDA orphan drug designation for Gastric Cancer Chimeric Therapeutics' CHM CDH17 received the FDA orphan drug designation for Gastric Cancer (Ref) The US FDA granted the orphan drug designation to Chimeric Therapeutics' CHM CDH17 (CDH17-targeting CAR-T cell therapy) in the treatment of Gastric Cancer. Dr Rebecca McQualter, CEO, Chimeric Therapeutics: “This is a great step forward in the development of CHM CDH17 to serve

07/12/2025 In Ph3 trial, Lilly's Jaypirca met its primary endpoint of ORR in CLL/SLL In Ph3 trial, Lilly's Jaypirca met its primary endpoint of ORR in CLL/SLL (Ref) The Phase 3 BRUIN CLL-314 trial of Eli Lilly and Company's pirtobrutinib (Jaypirca; BTK inhibitor) met its primary endpoint of non-inferiority on ORR vs ibrutinib in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who were treatment-naïve or were BTK inhibitor-naïve. ORR: 87.0% [

18/11/2025 AbbVie and Genmab's epcoritamab + rituximab + lenalidomide received FDA approval for R/R FL (Ref) The US FDA granted approval to AbbVie and Genmab's epcoritamab (bispecific CD20-directed CD3 T-cell engager) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the Phase 3 EPCORE FL-1 trial of the combo vs rituximab and lenalidomide Lorenzo Falchi, M.D., Ly

17/11/2025 Dewpoint Therapeutics' DPTX3186 received the FDA fast track designation for gastric cancer (Ref) The US FDA granted the fast track designation to Dewpoint Therapeutics' DPTX3186 (oral condensate modulator) for the treatment of gastric cancer. Isaac Klein, CSO and Head of R&D, Dewpoint Therapeutics: “We are honored that the FDA has recognized the urgency of gastric cancer and the promise of our condensate-based approach. DPTX3186 represents a new way of modulating d

13/11/2025 Kura Oncology and Kyowa Kirin's ziftomenib received FDA approval for certain R/R AML pts (Ref) The US FDA granted full approval to Kura Oncology and Kyowa Kirin's ziftomenib (KOMZIFTI™; menin inhibitor) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Troy Wilson, President and CEO, Kura Oncology: “KOMZIFTI combines compelling efficacy, a favor

22/09/2025 Nuvalent completed the NDA submission to the FDA for zidesamtinib in ROS +ve NSCLC (Ref) Nuvalent, Inc has completed its NDA submission to the US FDA for zidesamtinib (ROS1-selective macrocyclic tyrosine kinase inhibitor) in TKI pre-treated patients with advanced ROS1-positive NSCLC. SOPHiA GENETICS expanded its collaboration with AstraZeneca for an optimized NGS solution (Ref) SOPHiA GENETICS and AstraZeneca announced an expansion of their collaboration from the W

19/09/2025 Merck & Co/MSD received positive EU CHMP Opinions for perioperative pembrolizumab regimen in SCCHN, and for subcutaneous administration (Ref) The EMA's CHMP adopted a positive opinion recommending the approval of Merck & Co./MSD's pembro (anti-PD-1) mono as a neoadjuvant Tx followed by adjuvant pembro + RT ± cisplatin after surgery, then pembro mono for resectable locally advanced SCCHN with PD-L1 CPS ≥1. The recommendation is based on results from the Ph3 KEYNOTE

12/09/2025 The NDA for Alphamab Oncology and CSPC Pharma's anbenitamab + chemo has been accepted by the NMPA for HER2 +ve GC/GEJC (Ref) China's National Medical Products Administration accepted the NDA for Alphamab Oncology and CSPC Pharma's anbenitamab injection (KN026; anti-HER2 BsAb) in combination with chemotherapy for the treatment of HER2 +ve, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction cancer who have failed at least one prior system

28/08/2025 TOLREMO Therapeutics' TT125-802 received two fast track designations from the US FDA for NSCLC (Ref) The US FDA granted two fast track designations to TOLREMO Therapeutics' TT125-802 (CBP/p300 inhibitor) for the treatment of NSCLC: For the treatment of patients with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or exon 21 L858R substitution mutation, with disease progression on at least one line of prior therapy including an EGFR inhibitor For

18/08/2025 Izalontamab brengitecan received the Breakthrough Therapy Designation by the US FDA for EGFR-mutated NSCLC (Ref) The US FDA granted the Breakthrough Therapy Designation to SystImmune and Bristol Myers Squibb's izalontamab brengitecan (EGFR x HER3 bispecific ADC) for the treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR TKI and platinum

14/08/2025 Halda's HLD-0915 received the Fast Track Designation from the US FDA for mCRPC (Ref) The US FDA granted the Fast Track designation to Halda Therapeutics' HLD-0915 (androgen receptor-targeting RIPTAC) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). A Phase 1/2 trial of HLD-0915 in mCRPC is ongoing to evaluate the safety, tolerability, PK, PD, and anti-tumor activity Christian Schade, President and CEO, Halda Therapeutics:

12/08/2025 Perioperative pembrolizumab + enfortumab vedotin significantly improved EFS, OS and pCR in cisplatin-ineligible MIBC (Ref) The Phase 3 KEYNOTE-905/EV-303 trial of Merck & Co./MSD's pembrolizumab (Keytruda; anti-PD-1) + Astellas Pharma and Pfizer's enfortumab vedotin (Padcev; anti-Nectin-4 ADC) given before and after radical cystectomy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of EFS, as well as key second

29/07/2025 Calidi Biotherapeutics' CLD-201 received the US FDA Fast Track Designation for soft tissue sarcoma (Ref) The US FDA granted the Fast Track designation to Calidi Biotherapeutics' CLD-201 (SuperNova; allogeneic adipose stem-cell loaded oncolytic virus) for the treatment of soft tissue sarcoma. Guy Travis Clifton, CMO, Calidi: “FDA IND clearance and Fast Track designation represents an important milestone in the development of CLD-201. This designation underscores the

08/07/2025 Adagene and ConjugateBio sign a partnership agreement to develop novel ADC (Ref) Adagene announced a partnership with ConjugateBio to provide a proprietary antibody for use in partner companies’ bispecific ADC development programs Under the terms of the agreement, Adagene will receive an undisclosed upfront payment, as well as milestone and royalty payments Adagene will provide an internally developed antibody for novel bispecific ADC development Adagene retains al