Onco-Summaries: Daily Oncology Updates at a Glance

06/01/2026

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• Cellenkos' CK0804 received the FDA orphan drug designation for myelofibrosis

  
  

• Bayer's sevabertinib received the breakthrough therapy designation for HER2-mutant NSCLC

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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 milestone in the clinical development of CK0804 for myelofibrosis and underscores our commitment to advance CK0804 into phase 2 trials to address the unmet need for patients who have not responded to currently available therapies.

  
  

  • The observed increase in IL-10 and decreases in TGFβ levels in CK0804 responders, together with reductions in pathogenic monocytes in plasma and bone marrow, support the disease modifying potential of CK0804 Tregs as a distinct and differentiated therapeutic class in myelofibrosis."

Bayer's sevabertinib received the breakthrough therapy designation for HER2-mutant NSCLC (Ref)

The US FDA and China's CDE granted the breakthrough therapy designation to Bayer's sevabertinib (tyrosine kinase inhibitor) as a first-line therapy in patients with locally advanced or metastatic NSCLC with HER2 activating mutations.

• Christian Rommel, Ph.D., Head of Research and Development, Bayer’s Pharmaceuticals Division: “The Breakthrough Therapy Designation granted by the U.S. FDA and the CDE in China for sevabertinib as a potential first-line therapy in advanced HER2-mutant NSCLC, further underscore its potential to transform the lives of patients affected by this devastating cancer, which has limited treatment options and poor prognosis.

  
  

  • These latest regulatory milestones closely follow the recent accelerated FDA approval for sevabertinib in previously treated advanced HER2-mutant NSCLC and highlight Bayer’s commitment to develop precise and personalized healthcare solutions that address critical unmet needs and help improve outcomes and extend survival for these patients.”

    
    

• The designations are supported by results from the cohort F (patients who had not previously received treatment) of the ongoing Phase I/II SOHO-01/NCT05099172 trial