United States – On Monday, BioNTech (22UAy. DE) said the U. S. Food and Drugs Administration, or the FDA, has cleared a partial clinical hold on a phase one trial of its still unapproved cancer treatment.
The company has now incorporated further risk management steps into the investigator brochure and consent for patients as per the FDA standards as mentioned in BioNTech, as reported by Reuters.
Experimental Drug Targets Cancer Cells
The drug is an antibody-drug conjugate that was being tested in a trial conducted by China-based MediLink in patients with non-small cell lung cancer or breast cancer who had undergone other types of treatments.
ADCs are sometimes referred to as “guided-missile” cancer drugs because they are intended to target only cancerous cells, unlike standard chemotherapy, which is believed to minimize harm to healthy cells, as reported by Reuters.
Initial FDA Concerns Addressed
MediLink was informed that the US health regulator represents its concerns that BNT326/YL202, at higher doses, poses risks to humans of unreasonable and significant risk of becoming ill or suffering an injury.