Two Daiichi Sankyo drugs dealt a thumbs up and thumbs down by FDA advisory panel
Daiichi Sankyo was left with a bittersweet taste in its mouth after it saw one of its drugs recommended for FDA approval by the US agency’s Oncologic Drugs Advisory Committee (ODAC), but another of its products was turned down.
Firstly, pexidartinib was recommended after some uncertainty in the treatment of tenosynovial giant cell tumours (TGCT), a rare cancer of the tendon sheath. Concerns had originally been raised over the drug’s safety, but the committee eventually voted 12-3 in favour of recommendation. The decision was based on data illustrating that drug boasted a tumour response rate of 39% compared to no response with placebo after 25 weeks of treatment, and this was seen to outweigh concerns over elevated levels of liver toxicity in the pexidartinib compared to the placebo group.
In a separate voting session on the same day, quizartinib was rejected by 8-3 in the treatment of relapsed/refractory FLT3-ITD acute myeloid leukaemia (AML). The committee decided that the trial results submitted with the application, though they indicated that the drug met its target of improvement in overall survival, did not to assuage worries raised by FDA reviewers that flaws in the study design may have biased its results.
While these decision are not by any means binding, the FDA has historically followed the advice of the ODAC in most cases.
“While we are disappointed by the outcome of today’s ODAC vote, we will work closely with the FDA as it completes the review of our submission,” remarked Antoine Yver, Daiichi Sankyo’s Global Head of Oncology R&D.
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