Jeremy Bender, Day One CEO
Day One to file NDA for pediatric brain cancer drug by summer
Day One Biopharmaceuticals will ask regulators to approve its pediatric brain cancer drug tovorafenib before the second half of 2023, the biotech said Sunday.
The filing will include top-line data from a pivotal Phase II study that Day One reported over the weekend, showing that 64% of 69 evaluable patients responded to the monotherapy. Patients remained on treatment for a median of 8.4 months, with 77% of them still receiving the drug as of the Sept. 28, 2022 data cutoff.
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