FDA grants orphan drug status to Erasca brain cancer drug ERAS-801

The US Food and Drug Administration has granted orphan drug status to Erasca's (NASDAQ:ERAS) drug candidate ERAS-801 for the treatment of malignant brain tumors, including glioblastoma.

Erasca said the designation could entitle ERAS-801 to seven years of market exclusivity if it receives FDA approval. The drug received fast track status in April.

ERAS-801 is currently in Phase 1 testing as a monotherapy in patients with recurrent glioblastoma. Initial data from the study is expected during the second half of 2023.

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