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FDA issues fast track designation to MM-398 for metastatic pancreatic cancer
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The FDA granted fast track designation to an investigational nanoliposomal irinotecan injection as a potential treatment for patients with metastatic adenocarcinoma of the pancreas who underwent previous treatment with gemcitabine-based therapy.
Based on clinical research, the nanoliposomal irinotecan injection (MM-398, Merrimack Pharmaceuticals) allows longer drug exposure in the circulation, as well as more accumulation of the drug and its active metabolite SN-38 at the tumor site.
“It is crucial to develop new therapies for patients with pancreatic cancer, particularly for those patients who have previously received gemcitabine-based therapy where there is currently no consensus on the standard of care,” Eliel Bayever, MD, vice president at Merrimack and medical director for MM-398, said in a press release. “We will continue to work diligently on our [new drug application] submission in an effort to bring MM-398 to patients who are facing this aggressive disease as quickly as possible.”
The FDA based its decision on results of the phase 3 NAPOLI-1 trial, which included 417 patients with metastatic pancreatic cancer who had previously received gemcitabine-based therapy.
Results of the randomized, open-label trial showed that gemcitabine-refractory patients treated with the combination of MM-398 and standard second-line chemotherapy experienced improved OS and radiographic PFS compared with those who received chemotherapy alone.
The most common adverse events associated with the MM-398 combination were neutropenia (14.5%), fatigue (13.7%), diarrhea (12.8%) and vomiting (11.1%).