seattle_genetics

Four die in Seattle Genetics’ drug trial

pharmafile | January 3, 2017 | News story | Manufacturing and Production, Medical Communications, Sales and Marketing Seattle Genetics, patient deaths, trial hold 

Seattle Genetics released that the FDA had placed a hold had been placed on clinical trials involving its experimental cancer therapy drug vadastuximab talirine (SGN-CD33A) after six patients had experienced liver toxicity, with four patients dying as a result.

The trial that contained the deaths was a Phase 1/2 trial, which has been placed on hold by the FDA, while two other Phase 1 trials have been placed on partial hold. Over 300 patients have been treated with the experimental drug and Seattle Genetics are now working with the FDA to determine whether the drug was directly related to the incidence of liver toxicity.

The drug in question was developed to treat acute myeloid leukaemia via targeting and then destroying leukaemia cells in a fashion that is intended to limit damage to healthy cells. The drug had been perceived as promising enough to receive an orphan drug designation by the FDA and the EMA for the treatment AML.

This form of treatment is known to cause potential complications in patients who have undergone stem cell transplantation, as was part of the treatment process in trials affected. This is a common part of treatment and involves taking blood or bone-marrow stem cells from a donor before infusing them into patients after they have undergone radiation or chemotherapy.

The release of the news hit stocks in Seattle Genetics hard, with shares dropping by around $15. Seattle Genetics stressed that two others trials using SGN-CD33A, a Phase 1/2 and Phase 3, would continue enrolment.

Ben Hargreaves

Related Content

shutter

MSD partners up with Seattle Genetics in two oncology development deals potentially worth over $4bn

MSD has signed two new oncology-based deals with Seattle Genetics which together could be worth …

astellas_tokyo_copy_9

FDA approves Seattle Genetics and Astellas Pharma’s bladder cancer drug

The FDA has granted accelerated approval for Seattle Genetics and Astellas Pharma’s bladder cancer drug …

iannone

Immunomedics’ whirlwind in the C-suite continues

Immunomedics hasn’t had the most straight forward year, its $2 billion deal with Seattle Genetics …

Latest content