USFDA panel votes against Daiichi Sankyo blood cancer treatment Quizartinib
Independent experts on an advisory panel to the U.S. Food and Drug Administration on Tuesday voted against Daiichi Sankyo Co Ltd’s treatment for adults with a type of acute myeloid leukemia.
The panel voted 8-3 against the drug, quizartinib, after assessing data presented by the Japanese company.
Separately, an advisory committee voted 12-3 in favor of the approval of pexidartinib, another treatment from Daiichi, that aims to treat a type of rare, non-cancerous tumor usually affecting joints and limbs.
Daiichi has been focusing on oncology, targeting 500 billion yen ($4.52 billion) in annual sales from the business in fiscal 2025 from 20 billion yen in 2017.
Quizartinib is aimed at treating acute myeloid leukemia patients with a specific genetic mutation called FLT3.
While several members of the panel acknowledged the drug did appear to bridge patients toward a transplant, which could potentially cure them, they said the data presented was not strong enough to support an approval and called for further study.
“I believe in this drug but based purely on the data and evidence we were shown ... I don’t think this study has enough robust evidence,” one voting member said.
However, the panel supported strategies that the company proposed to mitigate the risk associated with pexidartinib, including educating healthcare providers about monitoring changes and modifying drug dosage as prescribed.
“Pexidartinib will be available only to stakeholders who have been trained and certified,” Daiichi executive Eric Richards said.
“It will be distributed only through specialty pharmacies and both wholesalers and pharmacies must complete a certification process to dispense pexidartinib.”
The FDA is expected to make a final decision on the approval of both treatments by August. The agency is not bound to follow the advice of its advisory panels but usually does so.
The panel voted 8-3 against the drug, quizartinib, after assessing data presented by the Japanese company.
Separately, an advisory committee voted 12-3 in favor of the approval of pexidartinib, another treatment from Daiichi, that aims to treat a type of rare, non-cancerous tumor usually affecting joints and limbs.
Daiichi has been focusing on oncology, targeting 500 billion yen ($4.52 billion) in annual sales from the business in fiscal 2025 from 20 billion yen in 2017.
Quizartinib is aimed at treating acute myeloid leukemia patients with a specific genetic mutation called FLT3.
While several members of the panel acknowledged the drug did appear to bridge patients toward a transplant, which could potentially cure them, they said the data presented was not strong enough to support an approval and called for further study.
“I believe in this drug but based purely on the data and evidence we were shown ... I don’t think this study has enough robust evidence,” one voting member said.
However, the panel supported strategies that the company proposed to mitigate the risk associated with pexidartinib, including educating healthcare providers about monitoring changes and modifying drug dosage as prescribed.
“Pexidartinib will be available only to stakeholders who have been trained and certified,” Daiichi executive Eric Richards said.
“It will be distributed only through specialty pharmacies and both wholesalers and pharmacies must complete a certification process to dispense pexidartinib.”
The FDA is expected to make a final decision on the approval of both treatments by August. The agency is not bound to follow the advice of its advisory panels but usually does so.
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