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.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Sahal Muhammed)
Comments