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

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

18/09/2025 Replimune completed a Type A meeting with the FDA to discuss the CRL for vusolimogene oderparepvec + nivo (Ref) Replimune announced the completion of a Type A meeting with the US FDA discussing the CRL for the BLA of vusolimogene oderparepvec (RP1; herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF) + nivo for the treatment of anti-PD-1 pretreated advanced melanoma. The feedback from the FDA provided during the me

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

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,

13/08/2025 Merck's perioperative Keytruda regimen received approval in Canada for resectable HNSCC with PD-L1 CPS ≥1 (Ref) Health Canada granted approval to Merck & Co./MSD's pembrolizumab (anti-PD-1) mono as a neoadjuvant treatment, then continued as adjuvant treatment in combination with RT +/- cisplatin and then as monotherapy for adult patients with resectable locally advanced HNSCC with PD-L1 CPS ≥1. The approval is based on results from the Phase 3 KEYNOTE-689 trial in

24/07/2025 GenFleet Therapeutics and Verastem Oncology's VS-7375 received the Fast Track Designation from the US FDA for pancreatic cancer (Ref) The US FDA granted the Fast Track Designation to GenFleet Therapeutics and Verastem Oncology's VS-7375 (oral KRAS G12D (ON/OFF) inhibitor) for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas, and for the treatment of patients with KRAS G12D-mutated locally adva

21/07/2025 Bayer and Orion Corporation’s Nubeqa™ received EU approval for mHSPC (Ref) The European Commission granted marketing authorization to Bayer and Orion Corporation’s darolutamide (Nubeqa; oral androgen receptor inhibitor) + androgen deprivation therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer The approval was based on results from the pivotal Phase 3 ARANOTE trial in which darolutamide + ADT significantly reduced the risk of rad

17/07/2025 Johnson & Johnson received Priority Review for TAR-200 from the US FDA in high-risk non-muscle invasive bladder cancer (Ref) The US FDA granted Priority Review to Johnson & Johnson's NDA filed for TAR-200 (intravesical gemcitabine releasing system) for the treatment of BCG-unresponsive, high-risk NMIBC with carcinoma in situ (CIS), with or without papillary tumors. The filing was based on results from the Phase 2b SunRISe-1 trial which demonstrated a CR of 82.4% wi

11/07/2025 Cel-Sci to partner with a leading Saudi Arabian pharma company for Multikine in the Tx of Head & Neck Cancer (Ref) Cel-Sci Corporation announced an agreement with one of Saudi Arabia’s premier pharmaceutical and healthcare companies for a partnership that spans regulatory and commercial activities for Multikine (Leukocyte Interleukin, Injection) in the Kingdom of Saudia Arabia The Saudi pharmaceutical partner which will file a Breakthrough Medicine Designation appl

07/07/2025 SIR-Spheres® Y-90 Resin Microspheres received FDA approval for HCC (Ref) The US FDA approved Sirtex Medical's SIR-Spheres Y-90 resin microspheres for the Tx of unresectable HCC The approval is based on the results from the prospective, multi-center, open-label DOORwaY90 trial DOORwaY90 met its prespecified primary endpoints with a ORR of 98.5%; the median DoR exceeded 300 days Matt Schmidt, CEO, Sirtex: "The expanded indication makes SIR-Spheres® the only Y-90 tr

04/07/2025 Imfinzi has been approved by the EC as a perioperative immunotherapy for muscle-invasive bladder cancer (Ref) AstraZeneca’s neoadjuvant durvalumab (Imfinzi; anti-PD-L1) in combination with gemcitabine and cisplatin followed by adjuvant durvalumab monotherapy after radical cystectomy for adult patients with resectable muscle-invasive bladder cancer (MIBC) has been approved in the EU The approval follows the positive CHMP opinion and is based on results from the Phas

29/04/2025 ALX Oncology’s Phase 2 ASPEN-03 & ASPEN-04 trials failed to meet the primary endpoint of ORR (Ref 1) ALX Oncology hit with a double blow in first-line R/M SCCHN as their Phase 2 ASPEN-03 & ASPEN-04 trials evaluating evorpacept, a CD47-blocker, in combination with pembrolizumab with or without chemotherapy did not meet the primary endpoints of improved ORR. While data showed trends in improvement versus historical controls, the signals were not strong enough to adva