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

October 1st Week, 2025 Regulatory Events 🎯 The US FDA approved Jazz Pharmaceuticals' lurbinectedin (DNA alkylating agent) + Roche's atezolizumab (anti-PD-L1) as a maintenance Tx for adults with ES-SCLC whose disease has not progressed after first-line induction Tx with atezolizumab, carboplatin and etoposide. (Ref 1) ❓ How is this approval expected to impact the Tx paradigm? 🎯 AstraZeneca and Daiichi Sankyo’s sBLA for trastuzumab deruxtecan (HER2 ADC) followed by paclitaxel

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

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

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

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

PD-(L)1 axis inhibits CAR-T cell activation, proliferation, survival, and functionality. Thus, CAR-T mediated direct targeting of the PD-(L)1 immunosuppressive axis or modulation of the axis along with CAR-T therapy holds a huge promise to unleash the full potential of CAR-Ts. Multiple strategies are under investigation to target PD-(L)1 immunosuppressive axis to increase CAR-T therapy efficacy. We have grouped the strategies under the following three broad categories, Combin

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