02/07/2026 Roche's Divarasib demonstrates superiority over approved KRAS G12C Inhibitors in Phase 3 NSCLC trial Roche's Divarasib demonstrates superiority over approved KRAS G12C Inhibitors in Phase 3 NSCLC trial (Ref) Roche's Phase 3 Krascendo 1 study of divarasib (next-generation KRAS G12C inhibitor) demonstrated statistically significant improvements in both progression-free and overall survival vs approved first generation KRAS G12C inhibitors sotorasib or adagrasib in pa

18/06/2026 US FDA accepts Roche’s sBLA for subcutaneous Lunsumio + Polivy in relapsed/refractory LBCL US FDA accepts Roche’s sBLA for subcutaneous Lunsumio + Polivy in relapsed/refractory LBCL (Ref) The US FDA has accepted Roche’s supplemental Biologics License Application (sBLA) for subcutaneous Lunsumio VELO (mosunetuzumab; CD20xCD3 T-cell engaging bispecific antibody) + Polivy (polatuzumab vedotin; CD79b targeting antibody-drug conjugate) in adults with relapsed/refractory

11/06/2026 FDA grants Priority Review for atezolizumab + chemo in stage III dMMR/MSI-H colon cancer Alembic wins tentative USFDA approval for Larotrectinib capsules FDA grants Priority Review for atezolizumab + chemo in stage III dMMR/MSI-H colon cancer (Ref) The FDA has accepted Roche’s supplemental Biologics License Application (sBLA) and granted priority review for Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with chem

02/06/2026 FDA accepts NDA and grants priority review to Roche’s giredestrant for early-stage ER+, HER2- breast cancer Candel’s CAN‑2409 Phase 3 in localized prostate cancer shows significant DFS benefit with favorable safety, supporting BLA filing in Q4 2026 Cycle Pharma secures FDA approval for CAVHANZA™, the first nilotinib ODT eliminating PPI/H₂RA timing restrictions to broaden Ph+ CML treatment flexibility FDA accepts NDA and grants priority review to Roche’s giredestran

09/03/2026 Johnson & Johnson's AKEEGA regimen received EC approval for the treatment of BRCA1/2-mutated mHSPC BMS announced positive Ph3 data of oral mezigdomide regimen in R/R Multiple Myeloma AstraZeneca and Daiichi Sankyo’s Enhertu received priority review status for HER2-positive early breast cancer Roche announced failure of the Phase 3 persevERA Breast Cancer trial Johnson & Johnson's AKEEGA regimen received EC approval for the treatment of BRCA1/2-mutated mHSPC (Ref)

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

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

23/07/2025 Roche's Itovebi regimen received approval in the EU for ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation (Ref) The European Commission approved Roche's inavolisib (Itovebi; PIK3CA inhibitor) + palbociclib + fulvestrant for the treatment of adult patients with PIK3CA-mutated, ER+ve, HER2-ve, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment The approval is bas

18/07/2025 ImCheck’s ICT01 received the Orphan Drug Designation for Acute Myeloid Leukemia (Ref) The US FDA granted the Orphan Drug Designation to ImCheck Therapeutics' ICT01 (anti-BTN3A) for the treatment of acute myeloid leukemia Stephan Braun, CMO, ImCheck Therapeutics: "Receiving FDA orphan drug designation for ICT01 is a significant recognition of ICT01’s innovative therapeutic potential to meet the urgent unmet medical needs of AML patients. This important regulatory m

22/06/2025 The Phase 3 STELLAR-303 trial of zanzalintinib + atezolizumab achieved significant OS benefit in metastatic colorectal cancer (Ref) Per topline results from the Phase 3 STELLAR-303/NCT05425940 pivotal trial, Exelixis' zanzalintinib (third-generation oral tyrosine kinase inhibitor) + Roche's atezolizumab (aPD-L1) demonstrated a statistically significant improvement in OS vs regorafenib in previously treated, non-microsatellite instability (MSI)-high metastatic color

Highlights from the CHMP May 2025 Meeting are out! ⭐ New Medicines 💊 Autolus Therapeutics' obecabtagene autoleucel (Aucatzyl; CD19 CAR-T cell therapy) for the treatment of adults from 26 years of age with R/R B cell precursor acute lymphoblastic leukaemia 👉 Positive opinion recommending the granting of a conditional marketing authorisation 💊 GSK's belantamab mafodotin (Blenrep; anti-BCMA ADC) for the treatment of adults with R/R multiple myeloma: 👉In combination with bort

12/06/2025 MAIA Biotechnology and Roche announce a master clinical supply agreement for hard-to-treat cancer therapies (Ref) MAIA Biotechnology entered into a clinical master supply agreement with Roche for future trials evaluating MAIA’s ateganosine (THIO; telomere-targeting agent) in combination with Roche's atezolizumab (Tecentriq; anti-PD-L1) for the treatment of multiple hard-to-treat cancers. Ateganosine's highly synergistic and effective activity in combination with at

The first-line metastatic Melanoma market is currently dominated by immune checkpoint inhibitors—BMS' Opdivo + Yervoy, Opdualag, Opdivo, and Merck/MSD's Keytruda. Other treatment options include BRAF/MEK inhibitors (for BRAF+ve pts). Currently, Opdivo + Yervoy is considered as the gold standard with an mOS of 71.9 months; however, it is associated with a high rate of Gr 3/4 TRAEs (62.6%). BMS' Opdualag, a combination of anti-LAG-3 (relatlimab) + anti-PD-1 (nivolumab), entered

Esophageal cancer is the fourteenth most commonly diagnosed cancer and the eighth leading cause of cancer-related death worldwide. The burden of esophageal cancer incidence and mortality is steadily increasing worldwide due to increased prevalence of associated risk factors such as tobacco and alcohol consumption, poor diet, sedentary lifestyle and obesity. Despite advancements in targeted therapies and immunotherapies, the prognosis of Esophageal cancer remains dismal, with

Cervical cancer ranks as the second most common feminine malignant tumor and the second leading cause of death among female cancers worldwide. Nearly 99% of cervical cancer cases are linked to HPV infection, making it largely preventable through HPV vaccination. Despite this, there were 604,127 new global cases and 341,831 deaths in 2020. Localized cervical cancer, which accounts for about 43% of all cases, has a five-year relative survival rate of 91.2%. However, locally adv

Acute myeloid leukemia (AML) is the most common type of leukemia among the adult population and accounts for about 80% of all cases. Despite development of novel treatment options and targeted therapeutics, the 5-year survival rate in adult population is quite low, indicating towards a huge unmet need in AML treatment space. The current infographic concisely highlights the key treatment options for AML and some of the emerging therapeutic stratagems.

Gastric cancer has remained one of the leading causes of cancer-related deaths globally. It was reported as the 5th most common cancer and the 4th leading cause of cancer death worldwide in 2020, with an observed trend of increasing incidence rates in younger adults (<50 years). Despite therapeutic progress, the survival rate for gastric cancer patients remains low, highlighting the unmet need for treatments of further potential. In this concise infographic, we highlight the

Breast cancer is the most commonly diagnosed cancer worldwide with a steady increase in incidence rate over the past decades. It is estimated that, if the current trends remain unchanged, the burden of breast cancer is set to grow to over 3 million new cases and 1 million deaths per year by 2040 as a result of population growth and ageing alone. The infographic highlights the current key options in Breast cancer's evolving treatment paradigm with a glimpse of the emerging the

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