26/06/2026 Henlius’ serplulimab secures EU approval for sqNSCLC FDA accepts RP1 BLA resubmission for advanced Melanoma; Decision expected by August 2026 FDA grants tentative approval for enzalutamide tablets, adding new dosing strengths to compete with Xtandi Henlius’ serplulimab secures EU approval for sqNSCLC (Ref) The European Commission approved serplulimab (Hetronifly®; anti-PD-1) in combination with chemotherapy for first-line treatment of unresectable locally advanced

16/06/2026 US FDA grants Fast Track to givastomig, in first‑line HER2‑negative metastatic gastric cancer US FDA grants Fast Track to givastomig, in first‑line HER2‑negative metastatic gastric cancer (Ref) ABL Bio & NovaBridge's givastomig, a CLDN18.2 x 4-1BB bispecific antibody, received Fast Track status in combination with nivolumab and chemotherapy for first-line HER2-negative advanced/metastatic gastroesophageal adenocarcinomas that are CLDN18.2 and PD-L1 positive Clinica

15/05/2026 FDA approved ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of neoadjuvant and adjuvant HER2+ early breast cancer UGN-103 delivers 94.5% six‑month durability in Phase 3 UTOPIA trial, with NDA submission planned for Q3 2026 to advance next‑generation RTGel therapy in recurrent LG‑IR‑NMIBC In Ph3 trial, Regeneron’s fianlimab + cemiplimab showed numeric PFS gain but missed statistical significance vs pembrolizumab in advanced or metastatic Melanoma CAN‑24

13/04/2026 FDA issues Complete Response Letter to Replimune’s RP1 BLA, halting accelerated approval path FDA Grants Priority Review for Ifinatamab Deruxtecan in ES-SCLC Daraxonrasib Demonstrates Unprecedented Survival Benefit in Phase 3 Pancreatic Cancer Trial Jaypirca (pirtobrutinib) combination significantly extended progression-free survival (PFS) in Relapsed/Refractory CLL/SLL SynOx Therapeutics' Phase 3 TANGENT Study Delivers Positive Results for TGCT Treatment IDEAYA an

20/03/2026 BMS received approvals from US FDA and EC for Opdivo-based treatment combinations for classical Hodgkin Lymphoma BMS received approvals from US FDA and EC for Opdivo-based treatment combinations for classical Hodgkin Lymphoma (Ref) The US FDA approved Bristol Myers Squibb's nivolumab (anti-PD-1) + doxorubicin + vinblastine + dacarbazine for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV cHL. Additionally,

11/12/2025 BMS' sBLA for Opdivo + AVD received the FDA priority review for first-line cHL BMS' sBLA for Opdivo + AVD received the FDA priority review for first-line cHL (Ref) The US FDA granted priority review status to Bristol Myers Squibb's sBLA for nivolumab (Opdivo; anti-PD-1) + doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric (12 years and older) patients with previously untreated stage III or IV classical Hodgkin Lymphoma (cHL). The FDA assigned a

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

22/07/2025 Replimune's BLA for vusolimogene oderparepvec + nivo received a CRL from the US FDA (Ref) The US FDA issued a Complete Response Letter (CRL) regarding the BLA for Replimune's vusolimogene oderparepvec (RP1; herpes simplex virus engineered with a fusogenic protein (GALV-GP R-) and GM-CSF) + nivolumab for the treatment of advanced melanoma. The CRL highlighted that the FDA was unable to approve the application in its present form due to the following reasons: The Ph1

24/06/2025 Opdivo + Yervoy received supplemental approval in Japan to expand the use for unresectable hepatocellular carcinoma (Ref) Ono Pharmaceutical and Bristol-Myers Squibb K.K. have received a supplemental approval of Opdivo (nivolumab; anti-PD-1) + Yervoy (ipilimumab; anti-CTLA-4) in Japan, to expand the use for the treatment of unresectable hepatocellular carcinoma (HCC) The approval is based on the results from the global Phase 3 CheckMate-9DW trial of nivo + ipi vs i

24/04/2025 Ivonescimab Plus Chemotherapy Shows Statistically Significant Superiority Over Tislelizumab in First-Line Treatment of Squamous NSCLC (Ref 1) Akeso and Summit Therapeutics' ivonescimab, a PD-1/VEGF bispecific antibody (BsAb), in combination with chemotherapy, met its primary endpoint of progression-free survival (PFS) in the Phase 3 HARMONi-6 trial versus tislelizumab (anti-PD-1) + chemotherapy as a first-line treatment of advanced, squamous non-small cell lung can

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

Bladder cancer is the most common malignancy of the urinary tract. As of 2022, Bladder Cancer had an incidence of 614,298 patients worldwide, and 220,596 patients succumbed to the disease. While the therapeutic approach to it remained largely unchanged for many years, recent clinical progress has paved the way towards a novel era of diagnosis and management of the disease, with several special designations and two very recent approvals by the US FDA. In December 2023, the FD

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

Renal cell carcinoma (RCC) stands as the predominant form of kidney cancer, comprising about 90% of kidney cancer cases. It accounts for roughly 3% of all cancer diagnoses, with a notably higher occurrence in Western countries, likely linked to the increased detection of small renal masses. Despite advancements in targeted therapies and immunotherapies, the prognosis for stage IV RCC remains challenging, with a 5-year survival rate of only 17%. Furthermore, non-clear cell RCC

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

In acknowledgment of Melanoma Awareness Month, Oncofocus presents a user-friendly infographic. It showcases a glimpse into top-level epidemiology data, key treatment options, and emerging therapies. Stay informed and help spread melanoma awareness with this publicly accessible infographic.

In recognition of Head and Neck Cancer Awareness Month, Oncofocus has released a concise and easy-to-read infographic that outlines the current approved therapies and noteworthy emerging therapies. Stay informed and help spread HNC awareness with this publicly accessible infographic.