US FDA approves Partner Therapeutics' bile duct cancer drug under Fast-Track review
The U.S. Food and Drug Administration has approved Partner Therapeutics' drug for adults with a rare form of bile duct cancer as part of a new Fast-Track review program, the agency said on Friday.Here are some details:
The antibody drug, branded Bizengri (Zenocutuzumab-zbco), is the first treatment approved for adults with advanced cholangiocarcinoma (bile duct cancer), whose tumors carry a rare genetic mutation and whose disease has worsened after prior treatment, the FDA said.The approval is the seventh granted under the FDA commissioner's National Priority Voucher pilot program to expedite reviews for treatments for rare diseases with few or no options.
In a study of 19 patients, 36.8% saw their tumors shrink with Bizengri.Responses lasted from 2.8 months to 12.9 months, the FDA said.Approval comes just two days after the privately held company was granted the fast-track voucher for the drug.Bizengri is already approved for certain adults with advanced lung and pancreatic cancers whose disease has progressed after prior treatment.
The FDA said serious side effects can include infusion reactions, lung inflammation and heart-related problems.Common side effects include diarrhea, pain, fatigue, nausea, shortness of breath and rashes.
Partner Therapeutics (PTx) is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative, late-stage therapies for cancer, infectious diseases, and severe, unmet medical needs.Founded in 2017 and based in Lexington, MA, the company focuses on improving patient outcomes through targeted oncology treatments and advanced immunotherapies.
Key Aspects of Partner Therapeutics:
Core Products: PTx acquired the global rights to Leukine (sargramostim), an immune-stimulant used for treating severe infections and in bone marrow transplantation.Key Pipeline: The company is developing Zenocutuzumab (Zeno), a bispecific antibody targeting NRG1-fusion positive solid tumors.
