09/06/2026 Imugene’s Azer-cel secures FDA Fast Track for CLL/SLL and MZL FDA grants RedHill’s opaganib Rare Pediatric Disease designation for neuroblastoma Serplulimab secures world‑first approval as a chemo‑sparing perioperative immunotherapy for gastric cancer FDA grants RMAT to lasme‑cel, advancing the first off‑the‑shelf CAR‑T into pivotal r/r B‑ALL trial Imugene’s Azer-cel secures FDA Fast Track for CLL/SLL and MZL (Ref) Imugene's Azer-cel (azercabtagene zapreleucel; CD1

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

14/05/2026 Alembic secures USFDA tentative nod for Darolutamide tablets, 300 mg In Ph3 VOLGA trial, durvalumab + enfortumab vedotin significantly improved EFS and OS in MIBC Celcuity expands Phase 3 VIKTORIA-2 trial to include endocrine‑sensitive HR+/HER2‑ breast cancer patients Astellas files sNDA in Japan for PADCEV + Keytruda in cisplatin‑eligible muscle‑invasive bladder cancer, backed by Phase 3 EV‑304 survival benefit Alembic secures USFDA tentative nod for Darolutamide

06/01/2026 Cellenkos' CK0804 received the FDA orphan drug designation for myelofibrosis Bayer's sevabertinib received the breakthrough therapy designation for HER2-mutant NSCLC Cellenkos' CK0804 received the FDA orphan drug designation for myelofibrosis (Ref) The US FDA granted the orphan drug designation to Cellenkos' CK0804 (CXCR4hi Treg therapeutic) for treatment of myelofibrosis. Dr. Simrit Parmar, MD, Founder, Cellenkos: "Receiving Orphan Drug Designation is an important

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

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

Thyroid Cancer, despite a good prognosis, has been a cause of concern over the past years. Thyroid Cancer shows no symptoms in the early stage, but its increasing rate of occurrence indicates the need for further diagnostic and therapeutic options. In observance of Thyroid Cancer Awareness month, Oncofocus is pleased to present an infographic highlighting the key options with a glimpse of the emerging therapies in the Thyroid cancer treatment paradigm.

In observance of Sarcoma Awareness Month, Oncofocus is pleased to present a user-friendly infographic. This comprehensive visual presentation aims to elucidate crucial aspects such as epidemiology, key treatment options, and emerging therapies related to sarcoma. By staying informed and actively participating in sharing this publicly accessible infographic, we can collectively raise awareness about sarcoma and its implications. Together, let us make a positive impact during S

Biliary tract cancers, encompassing bile duct and gallbladder malignancies, originate from the bile duct epithelium. Cholangiocarcinoma, or bile duct cancer, affects approximately 8,000 individuals annually in the United States, while gallbladder cancer is even less common, with an incidence rate of about 2 per 100,000 people. These cancers are frequently diagnosed at advanced stages, leading to poor prognoses. In the US and EU, treatment options remain scarce, although recen