NEW
YORK, Aug. 3, 2023 /PRNewswire/ -- Delcath
Systems, Inc. (Nasdaq: DCTH), an interventional oncology company
focused on the treatment of primary and metastatic cancers of the
liver, announced that it plans to report the Company's 2Q23
earnings and issue its Form 10-Q the week of August 7, 2023. Subsequently, shortly after the
FDA's decision on its HEPZATO™ KIT's new drug application
("NDA") resubmission, Delcath expects to hold a conference call to
review the quarter and the details of the FDA action. Delcath
currently expects the FDA to finish their review and take action on
the application by the August 14,
2023 Prescription Drug User Fee Act ("PDUFA") date.
About Delcath Systems, Inc.
Delcath Systems, Inc. is an interventional oncology company
focused on the treatment of primary and metastatic liver cancers.
The company's proprietary products, HEPZATO KIT (melphalan
hydrochloride for Injection/Hepatic Delivery System) and
CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous
hepatic perfusion (PHP) are designed to administer high-dose
chemotherapy to the liver while controlling systemic exposure and
associated side effects during a PHP procedure.
In the United States, HEPZATO KIT is considered an
investigational drug/device combination product regulated as a drug
by the United States Food and Drug Administration (FDA).
HEPZATO KIT is comprised of the chemotherapeutic drug melphalan
and Delcath's proprietary Hepatic Delivery System (HDS).
The HDS is used to surgically isolate the liver while
simultaneously filtrating hepatic venous blood during melphalan
infusion and washout. The use of the HDS results in loco-regional
delivery of a relatively high melphalan dose, which can potentially
induce a clinically meaningful tumor response with minimal
hepatotoxicity and reduce systemic exposure. In the US, HEPZATO KIT
was the subject of a February 14, 2023 new drug
application resubmission to FDA for the treatment of patients with
unresectable hepatic-dominant metastatic ocular melanoma (mOM),
also known as metastatic uveal melanoma (mUM). FDA has established
an August 14, 2023 PDUFA date for the resubmission.
In Europe, the device-only configuration of the HDS is
regulated as a Class III medical device and is approved for sale
under the trade name CHEMOSAT Hepatic Delivery System for
Melphalan, or CHEMOSAT, where it has been used in the conduct of
percutaneous hepatic perfusion procedures at major medical centers
to treat a wide range of cancers of the liver.
Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com
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SOURCE Delcath Systems, Inc.