FDA halts California drugmaker’s CAR-T trial after patient death

The FDA halted San Diego-based drugmaker Poseida Therapeutics’ clinical trial of a CAR-T therapy after a patient died, according to an Aug. 17 Securities and Exchange Commission filing.

Advertisement

The phase 1 trial was investigating a CAR-T gene therapy called P-PSMA-101, designed to treat prostate cancer. 

The patient had metastatic castrate-resistant prostate cancer and died of liver failure 19 days after receiving the CAR-T treatment. He had missed two follow-up visits and developed symptoms that led to him  being hospitalized, according to the SEC filing. 

Poseida is waiting on a formal response from the FDA and preparing recommendations to allow the trial to resume, the drugmaker said. 

The drugmaker’s shares fell 35 percent after the announcement.

More articles on pharmacy:
CVS partnering with Delta Air Lines for rapid COVID-19 testing program
Sanofi inks $3.68B deal to buy California autoimmune drugmaker
US to test benefits of remdesivir with second drug

Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit

Advertisement

Next Up in Pharmacy

Advertisement

Comments are closed.