US FDA approves Partner Therapeutics' bile duct cancer drug under fast-track review
May 8 (Reuters) - 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, is the first treatment approved for adults with advanced cholangiocarcinoma, 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.
