2023-03-27 08:53:45 ET
- Oncology-focused healthcare equipment maker Delcath Systems ( NASDAQ: DCTH ) announced Monday that the FDA accepted its resubmitted new drug application (NDA) for the HEPZATO Kit for certain liver-dominant eye cancer.
- The FDA has issued August 14, 2023, as the PDUFA date for its decision. In February, the company announced the refiling of the marketing application following Complete Response Letter received in 2013.
- With the NDA, the company seeks FDA clearance to use the drug-device combination in patients with unresectable hepatic-dominant metastatic ocular melanoma (mOM), an eye cancer with a primary impact on the liver.
- "We believe that HEPZATO, if approved, will be an important option for treating patients with mOM," Chief Executive Gerard Michel remarked.
- Delcath ( DCTH ) added ~6% on the regulatory win, which was simultaneously announced with the company's Q4 2022 results on Monday.
For further details see:
Delcath wins FDA review for cancer drug device