- The FDA on Thursday approved Merrimack's Onivyde (irinotecan liposome injection) for treatment of metastatic pancreatic cancer and is the first new drug approved for the condition in decades.
- Pancreatic cancer is considered difficult to treat. Although it represents 3% of all tumors, it is the fourth leading cause of cancer death. This is often because diagnosis is challenging due to nonspecific symptoms. Early diagnosis is associated with better outcomes.
- In a phase 3 study of 417 patients with metastatic pancreatic cancer, those treated with Onivyde combined with chemotherapy lived an average of 6.1 months, compared with 4.2 months for patients only treated with chemotherapy. Likewise, in each treatment group, patients experienced no tumor growth for 3.1 and 1.5 months, respectively.
According to the American Society of Clinical Oncology, the one-year survival rate for patients with pancreatic cancer is 28%, while the five-year survival rate is 7%. After years of not having new drugs for pancreatic cancer patients, the arrival of Onivyde may signal the beginning of a new era in which new therapies will become available for the treatment of pancreatic cancer.
In addition to the efficacy study, Merrimack, which is based in Cambridge, MA, also conducted a safety study in 398 patients. The most serious adverse event was neutropenia (abnormally low white blood cell count)—and there is a black box warning because of this and the risk of severe diarrhea.
Onivyde is Merrimack's first approval. The company was founded by scientists from MIT and Harvard, and has successfully introduced a first-in-class product the first time out the gate.