02/10/2025 Aminex Therapeutics' AMXT 1501 + DFMO received the FDA Orphan Drug Designation for Neuroblastoma (Ref) The US FDA granted the Orphan Drug Designation to Aminex Therapeutics' AMXT 1501 (polyamine transport inhibitor) + difluoromethylornithine for the treatment of patients with neuroblastoma. Mark Burns, CSO and President, Aminex Therapeutics: "Receiving Orphan Drug Designation for AMXT 1501 in combination with DFMO represents an important milestone in our mission to

01/10/2025 The US FDA accepted the sBLA for Enhertu® followed by THP for HER2+ve early-stage Breast Cancer (Ref) Daiichi Sankyo and AstraZeneca’s sBLA for famtrastuzumab deruxtecan-nxki (ENHERTU; HER2 ADC) followed by paclitaxel, trastuzumab and pertuzumab (THP) has been accepted for review by the US FDA for the neoadjuvant treatment of adult patients with HER2 +ve stage 2/3 breast cancer. The acceptance is based on results from the Phase 3 DESTINY-Breast11 trial The PDUFA da

30/09/2025 Umoja Biopharma's UB-VV111 in vivo CAR T cell therapy received the FDA fast track designation for B-Cell Malignancies (Ref) The US FDA granted the fast track designation to Umoja Biopharma's UB-VV111 (off-the-shelf drug product that generates CD19-directed CAR T cells in vivo) for the treatment of relapsed/refractory Large B-cell Lymphoma following two or more lines of prior therapy and relapsed/refractory Chronic Lymphocytic Leukemia following two or more lines of

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

17/09/2025 Rgenta Therapeutics' RGT-61159 received the FDA Orphan Drug Designation for ACC (Ref) The US FDA granted the Orphan Drug Designation to Rgenta Therapeutics' RGT-61159 (small molecule inhibitor of MYB) for the treatment of adenoid cystic carcinoma (ACC). The asset is currently being evaluated in a Phase 1a/b clinical trial in patients with advanced relapsed or refractory ACC or colorectal cancer Travis Wager, Co-founder and CSO, Rgenta: “Granting of ODD by the FDA h

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

11/09/2025 Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan has been accepted for review in the EU for HER2 +ve solid tumors (Ref) The EMA validated the Type II Variation marketing authorization application for Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan (ENHERTU; HER2 ADC) for the treatment of adult patients with HER2 +ve, unresectable or metastatic solid tumors who have received prior treatment and have no satisfactory alternative treatment options. The a

10/09/2025 Greenwich LifeSciences' GLSI-100 received the FDA fast track designation for HER2+ve breast cancer (Ref) The US FDA granted the Fast Track Designation to Greenwich LifeSciences' GLSI-100 (GP2 + GM-CSF) for the treatment of patients with HLA-A*02 genotype and HER2+ve breast cancer who have completed treatment with standard of care HER2/neu targeted therapy. Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, Greenwich: "Greenwich is pleased that the FDA sees the

09/09/2025 Johnson & Johnson's INLEXZO received US FDA approval for NMIBC (Ref) The US FDA approved Johnson & Johnson's INLEXZO™ (TAR-200; gemcitabine intravesical system) for the treatment of adult patients with BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. The approval is based on results from the Phase 2b SunRISe-1/NCT04640623 trial Jennifer Taubert, Executive Vice President, Worldwide Chairman,

01/09/2025 Boehringer’s zongertinib received accelerated approval in China for HER2-mutant advanced NSCLC ( Ref ) China’s National...

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

27/08/2025 BeOne Medicines' perioperative tislelizumab regimen received approval from the EC for resectable NSCLC (Ref) The EC approved BeOne Medicines' tislelizumab (TEVIMBRA; anti-PD-1) + platinum-containing chemotherapy as neoadjuvant treatment followed by tislelizumab monotherapy as adjuvant treatment for adult patients with resectable NSCLC at high risk of recurrence. The approval was based on results from the China-specific Phase 3 RATIONALE-315 trial Per pre-planned fi

26/08/2025 Genmab's Rina-S ADC received the Breakthrough Therapy Designation from the FDA for endometrial cancer (Ref) The US FDA granted the Breakthrough Therapy Designation to Genmab's rinatabart sesutecan (FRα-directed, TOPO1-inhibitor ADC), for the treatment of adult patients with recurrent or progressive endometrial cancer who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy. The designation was based on re

25/08/2025 Quest Diagnostics' Haystack MRD® test received the Breakthrough Device Designation from the FDA for colorectal cancer (Ref) The US FDA granted the Breakthrough Device Designation for Quest Diagnostics' Haystack MRD® test for identifying MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling. Dan Edelstein, Vice President and General Mana

21/08/2025 In a $350M deal, Kite to acquire Interius BioTherapeutics (Ref) Kite (a Gilead Company) entered into a definitive agreement to acquire Interius BioTherapeutics developing in vivo CAR therapeutics for $350 million. Interius’ off-the-shelf and personalized approach is designed to be delivered via a single IV infusion, eliminating the need for preconditioning chemotherapy and complex cell processing Under the terms of the agreement, Kite will acquire all of the outsta

Health Canada approved Bristol Myers Squibb's nivolumab (Opdivo; anti-PD-1) + ipilimumab (Yervoy; anti-CTLA-4) for the first-line treatment of adult patients with: Unresectable or metastatic MSI-H/dMMR colorectal cancer, and Unresectable or advanced hepatocellular carcinoma

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

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

11/08/2025 IO Biotech's Cylembio + pembrolizumab demonstrated clinical improvement in PFS as a first-line treatment of Melanoma, but statistical significance was narrowly missed (Ref) IO Biotech announced topline results from the pivotal Phase 3 IOB-013 trial of Cylembio (imsapepimut and etimupepimut, adjuvanted; IDO and PD-L1 vaccine) + pembrolizumab vs pembrolizumab alone as a first-line treatment of advanced melanoma. The combo demonstrated clinical improvement in PFS vs p