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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