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Kronos Bio Doubles Its Cash With $155m Financing

The cancer drug developer led by former Gilead R&D head Norbert Bischofberger will start a registrational trial for its recently acquired SYK inhibitor and the first trial for its CDK9 inhibitor.

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Real-World Evidence: Epizyme’s Epithelioid Sarcoma Natural History Study Falls Flat At US FDA

Sponsor had hoped to use retrospective case review study as an external control arm to support regular approval of tazemetostat; US FDA not only rejected this idea, it found the study design so flawed that it did not consider the results in its efficacy assessment for accelerated approval.

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Confirmatory Trial Worries Clouded Tazverik’s Accelerated Approval

Given the rarity of epithelioid sarcoma, ‘the possibility exists that this trial will not be completed,’ Division of Oncology 3 acting director Steven Lemery said in recommending approval; confirmatory trial is not expected to complete until 2029, and FDA reviewers suggest it may be underpowered to show an effect on progression-free survival. (Part 2 of our Drug Review Profile on the product.)

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Tazverik Clinical Development Timeline

Chronicle of the development and review of Epizyme’s epithelioid sarcoma treatment tazemetostat.

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