IU205 - Use of PEDMARK to Reduce Cisplatin-Induced Ototoxicity in Pediatric Patients

Friday, April 21, 2023

12:00 PM – 12:30 PM PDT

Location: IU Room 5 Hall 4F ** 705 Pike

Earn 0.05 CEUs

Lead Presenter(s)

DL

Donna Lee, APRN ACNS-BC

Director Field Medical
Fennec
Huntingdon Valley, Pennsylvania

Disclosure(s): Fennec Pharmaceuticals: Employment (Ongoing)

Presenter(s)

AB

Ananya Bhattacharya, PhD (she/her/hers)

Head of Medical Affairs
Fennec
lawrenceville, New Jersey

Disclosure(s): Fennec: Employment (Ongoing)

PDF Slides

Cisplatin induced-ototoxicity (CIO) is observed in up to 70% of pediatric patients. The efficacy and safety of PEDMARK in reducing the risk of CIO was evaluated in two phase 3 clinical studies: SIOPEL 6 and COG ACCL0431. The incidence of hearing loss was lower in the PEDMARK + cisplatin arm compared with the cisplatin alone arm in both studies with an acceptable safety profile. Additionally, PEDMARK has been provided to patients via the Named Patient Program (NPP), spanning 48 hospitals in 14 countries. One serious grade 1 adverse event (AE), metabolic acidosis, has been observed.