- Fennec Pharmaceuticals (FRX) resubmits new drug application to U.S. Food and Drug Administration for PEDMARK™
- If approved by the FDA, PEDMARK stands to be the first therapy for the prevention of Cisplatin-induced hearing loss in children
- This resubmission is for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one
- In the U.S. and Europe, it is estimated that, annually, over 10 thousand children may receive platinum-based chemotherapy
- Fennec Pharmaceuticals Inc. (FRX) is up 10.28 per cent and is trading at C$9.00 at 2:09 pm ET
Fennec Pharmaceuticals Inc. (FRX) announced the resubmission of its new drug application to the U.S. Food and Drug Administration (FDA) for PEDMARK™.
This resubmission is for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumours.
The resubmission for PEDMARK follows receipt of final minutes from a Type A meeting with the FDA.
Importantly, the Complete Response Letter received on August 10, 2020, referred to deficiencies with the facility of the drug product manufacturer; no clinical safety or efficacy issues were identified and there was no requirement for further clinical data.
“We are pleased to have resubmitted the NDA for PEDMARK™ and look forward to working with the FDA through the review process,” said Rosty Raykov, Chief Executive Officer of Fennec Pharmaceuticals, Inc.
“We remain committed to reducing the risk of life-long hearing loss for children receiving cisplatin chemotherapy. If approved, PEDMARK stands to be the first FDA-approved therapy to reduce the risk of cisplatin-induced ototoxicity in pediatric patients,” added Raykov.
Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies.
Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to the survivors of pediatric cancer.
In the U.S. and Europe, it is estimated that, annually, over 10,000 children may receive platinum-based chemotherapy.
The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids.
PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed.
The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumour, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumours.
The Marketing Authorization Application (MAA) for sodium thiosulfate is currently under evaluation by the European Medicines Agency (EMA).
PEDMARK received breakthrough therapy and fast track designation from the FDA in March 2018.
Fennec Pharmaceuticals Inc. (FRX) is up 10.28 per cent and is trading at C$9.00 at 2:09 pm ET.
