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United States FDA approves Merrimack's ONIVYDE in combination with fluorouracil and leucovorin.

M2 EQUITYBITES-October 23, 2015-United States FDA approves Merrimack's ONIVYDE in combination with fluorouracil and leucovorin


The United States FDA has approved Merrimack's (NASDAQ: MACK) ONIVYDE (irinotecan liposome injection) in combination with fluorouracil (5-FU) and leucovorin (LV) on October 22.

The product is intended for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

ONIVYD is a proprietary liposomal encapsulation of irinotecan, a topoisomerase inhibitor. The NDA for ONIVYDE was based on the results of the international Phase three study (NAPOLI-1). ONIVYDE plus 5-FU/LV achieved the study's primary endpoint by indicating a clinically and statistically significant improvement in overall survival, and demonstrating improvement in progression free survival compared to the control group of patients who received 5-FU/LV alone.

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Publication:M2 EquityBites (EQB)
Date:Oct 23, 2015
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