On May 16, 2018 Delcath Systems, Inc. (OTCQB:DCTHD), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the German Guidelines Program in Oncology (GGPO) has included treatment with Delcath’s CHEMOSAT in the German national treatment guidelines for liver metastases from melanoma (Press release, Delcath Systems, MAY 16, 2018, View Source;p=RssLanding&cat=news&id=2349370 [SID1234526685]). This inclusion of treatment with CHEMOSAT is in the S3 Guidelines, which represents the highest level within the classification of the guidelines indicating that it is based on evidence and consensus within the German clinical community.
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The GGPO’s update was based on its evaluation of published data on treatment with CHEMOSAT as a loco-regional treatment for melanoma liver metastases. Following this evaluation, and after soliciting additional feedback from the oncology community in Germany, treatment with CHEMOSAT was classified with Evidence Level 1B, indicating the second highest level of evidence. Treatment with CHEMOSAT is the sole therapy classified with this top designation. Other loco-regional therapies previously included in the guidelines have been designated with Evidence Level 4, indicating an absence of clinical trial supporting evidence.
"Inclusion in the GGPO treatment guidelines reflects the steady accumulation of both clinical data and experience built with our therapy in Germany over the last several years," said Jennifer K. Simpson, PhD, MSN, CRNP, President and Chief Executive Officer of Delcath Systems. "Importantly, the guidelines established that treatment with CHEMOSAT is the best supported option for patients with melanoma liver metastases based on current evidence. Through our Clinical Development Program and our commercialization efforts in Germany and other European markets, we are working toward establishing treatment with CHEMOSAT as a first line treatment option for appropriately selected patients.