FDA News

FDA grants fast track designation to MM-398 for metastatic pancreatic cancer

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 have been previously treated with gemcitabine-based therapy, the drug’s manufacturer announced.

Based on clinical research, the nanoliposomal irinotecan injection (MM-398, Merrimack Pharmaceuticals) allows longer drug exposure in the circulation and more accumulation of the drug and its active metabolite SN38 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 patients treated with the combination of MM-398 and standard second-line chemotherapy experienced improved OS and radiographic PFS compared with chemotherapy alone in gemcitabine-refractory patients.

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%).

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 have been previously treated with gemcitabine-based therapy, the drug’s manufacturer announced.

Based on clinical research, the nanoliposomal irinotecan injection (MM-398, Merrimack Pharmaceuticals) allows longer drug exposure in the circulation and more accumulation of the drug and its active metabolite SN38 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 patients treated with the combination of MM-398 and standard second-line chemotherapy experienced improved OS and radiographic PFS compared with chemotherapy alone in gemcitabine-refractory patients.

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%).