STI Pharma is launching its first oncology injectable. The Newtown, Pa.-based company has introduced a generic of Bicnu (carmustine for injection). The generic of AVET’s (formerly Heritage’s) drug will be available in 100mg per vial and diluent dosage strength, and has previously been approved by the Food and Drug Administration.
The drug is a nitrosurea, indicated as a palliative therapy on its own or in combination with other drugs for various types of brain tumors, multiple myeloma, relapsed or refractory Hodgkin’s lymphoma and relapsed or refractory non-Hodgkins lymphoma.
STI’s carmustine is manufactured in the United States and is sourced exclusively from the original product’s source of active pharmaceutical ingredients, the company said.
"The launch of carmustine injection is an important milestone for STI, representing our first oncology injectable approval," said STI President Frank Mullery. "Our injectable pipeline demonstrates our commitment to expanding access to medicine in key therapeutic areas such as Oncology. I look forward to partnering with our customers across the Hospital and Clinic channels to successfully launch carmustine."
The product had U.S sales of roughly $75 million for the year ended December 31, 2018, according to IQVIA data.
STI said that it currently has two abbreviated new drug applications pending before the FDA, with a pipeline that it said represents roughly $400 million in annual sales based on IQVIA data.