The Center for Drug Evaluation (CDE) has granted priority review status to two drugs: Suzhou Ascentage Pharma’s olverembatinib and Roche’s crovalimab. The designations aim to accelerate regulatory timelines for these therapies targeting unmet medical needs.
Ascentage’s Olerembatinib
- Drug Profile: Olerembatinib, an oral third-generation BCR-ABL tyrosine kinase inhibitor (TKI), received conditional approval in China on November 25, 2021, for chronic and accelerated phase chronic myeloid leukemia (CML CP/AP) with T315I mutation resistance.
- Priority Review: The latest nod targets CML CP patients resistant to or intolerant of first- and second-generation TKIs, aiming to streamline approval for this critical patient group.
Roche’s Crovalimab
- Drug Profile: Crovalimab, a next-generation C5 inhibitor developed via Roche’s Smart-Ig technology, blocks complement C5 cleavage, inhibiting downstream activation.
- Priority Review: The indication covers paroxysmal nocturnal hemoglobinuria (PNH), with Phase III data in May 2024 showing positive results in this rare disease.-Fineline Info & Tech
