Setbacks

FDA padlocks any new human tests on Seattle Genetics’ cancer drug in the wake of more deaths

Clay Siegall, CEO, Seattle Genetics

In the wake of Seattle Genetics’ announcement that a disturbing tilt in deaths pointed to a likely safety problem for its late-stage cancer drug vadastuximab talirine (SGN-CD33A), the FDA has stepped in to yank the IND and officially put any human testing on hold.

The biotech $SGEN reported the FDA’s move in a filing with the SEC this morning.

Seattle Genetics had already hit the brakes on its R&D work on the drug three days ago, scrapping the Phase III for acute myeloid leukemia and ordering a halt to any other testing until they can get a better read on the situation. It will also have to convince regulators that the drug is safe for testing— after the FDA had lifted its first clinical hold on the drug just three months ago. That first hold on its early-stage work came after four patients died.

Those deaths were linked to liver toxicity, a classic red flag on safety. But this time one of the few clues provided by Seattle Genetics is that liver toxicity did not appear to be behind the disturbing rate of deaths investigators were seeing.

Back in March the biotech reported that it was getting restarted on the clinical work after it came up with “revised eligibility criteria and stopping rules for veno-occlusive disease.” The FDA agreed to lift the hold only two months after it was dropped on Seattle Genetics.

With its big Immunomedics deal axed by activists and its lead clinical drug in big trouble, Seattle Genetics CEO Clay Siegall will come under heavier pressure to diversify beyond Adcetris.


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RAPS Regulatory Convergence 2017