Onco-Summaries: Daily Oncology Updates at a Glance

15/09/2025

Daiichi and Merck's raludotatug deruxtecan received the Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (Ref)

The US FDA granted the Breakthrough Therapy Designation to Daiichi Sankyo and Merck & Co./MSD's raludotatug deruxtecan (R-DXd; CDH6-directed ADC) for the treatment of adult patients with platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with bevacizumab.

• Ken Takeshita, Global Head, R&D, Daiichi Sankyo: “Patients have limited treatment options once ovarian cancer becomes resistant to platinum-based chemotherapy, highlighting the urgent need for new medicines that can improve patient outcomes. The receipt of Breakthrough Therapy Designation represents an important step forward in our efforts to advance raludotatug deruxtecan as a novel medicine for patients with CDH6 expressing platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers previously treated with bevacizumab.”

  
  

• Eliav Barr, SVP, Head of Global Clinical Development and CMO, Merck Research Laboratories: “The FDA’s Breakthrough Designation is a reflection of our commitment to advancing research for patients impacted by women’s cancers. Raludotatug deruxtecan has the potential to one day become an important option for the treatment of patients with CDH6-expressing platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers previously treated with bevacizumab, and we are excited to share data from REJOICE-Ovarian01 with the scientific community at an upcoming medical meeting and to continue working closely with the FDA.”

Novocure's Optune Lua® has been approved by Japan's MHLW for previously treated NSCLC (Ref)

Japan’s Ministry of Health, Labour and Welfare approved Novocure's Optune Lua® (tumor treating fields) for concurrent use with PD-1/PD-L1 inhibitors for the treatment of adult patients with unresectable advanced/recurrent NSCLC who have progressed on or after platinum-based chemotherapy.

• The approval was supported by the Phase 3 LUNAR trial of Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel vs PD-1/PD-L1 inhibitors or docetaxel alone for patients with metastatic NSCLC who progressed during or after platinum-based therapy

  
  

• Frank Leonard, President, Novocure: “Lung cancer is the leading cause of cancer-related death worldwide, and unfortunately, in Japan the number of cases continue to increase, which is why we see an urgent need for innovative treatment options for this disease. Novocure is focused on launching Optune Lua as quickly as possible in Japan so that patients with non-small cell lung cancer experiencing a progression after initial platinum-based treatment have access to our therapy.”

Akeso's ligufalimab received the FDA Orphan Drug Designation for AML (Ref) 

The US FDA granted the Orphan Drug Designation to Akeso's ligufalimab (AK117; anti-CD47) for the treatment of acute myeloid leukemia.

• Clinical trials have shown promising outcomes with ligufalimab + azacitidine as a first-line treatment of AML

  
  

• Akeso has launched a Phase 2 trial evaluating ligufalimab + venetoclax + azacitidine as a first-line treatment of AML patients ineligible for intensive chemotherapy