- Delcath Systems ( NASDAQ: DCTH ) announced Tuesday the company resubmitted a new drug application (NDA) to the FDA, seeking approval for the drug delivery device HEPZATO Kit as a treatment for certain patients with hepatic-dominant metastatic ocular melanoma.
- HEPZATO Kit is designed to administer high-dose chemotherapy to the liver while controlling systemic side effects.
- The NDA refiling follows a Complete Response Letter the FDA issued for HEPZATO Kit in 2013, rejecting its approval.
- “The NDA resubmission contains comprehensive data and information to address all issues identified in the CRL,” the company said, adding that the FDA feedback on the filing is expected within 30 days.
- Read: In 2021, Delcath ( DCTH ) disclosed Phase 3 results for HEPZATO Kit from patients with liver-dominant metastatic ocular melanoma.
For further details see:
Delcath resubmits marketing application for cancer drug device