PharmaEngine, Incorporated has received approval from the U.S. Food and Drug Administration for an investigational new drug (IND) application submitted for the investigative agent PEP02 (liposome irinotecan injection) in the treatment of pancreatic cancer.

PEP02 is an encapsulated liposomal formulation of irinotecan hydrochloride (Camptosar®). Although still in early trials, PEP02—either alone or in combination with other chemotherapy agents—has demonstrated improved pharmacokinetic, safety, and efficacy profiles compared with other formulations of irinotecan.

PharmaEngine plans to enroll patients with pancreatic cancer who have failed Gemzar® (gemcitabine) to a Phase II trial evaluating PEP02 in 2009.

Recommended Articles

Image placeholder title

COVID-19 Vaccines and Cancer-FDA Recommends "Booster"

COVID-19 vaccination answers to frequently asked questions about vaccination and cancer-updated August 12th

Liver

Treatment & Management of Liver Cancer

Surgery, liver directed therapies, immunotherapy and precision cancer medicines are used to treat liver cancers.

Image placeholder title

Enhertu Treatment of Her2 positive Non-Small Cell Lung Cancer

The precision cancer medicine Enhertu effectively targets HER2 over expressing NSCLC - trials ongoing.