Erasca Granted FDA Orphan Drug Designation For CNS-Penetrant EGFR Inhibitor ERAS-801 For The Treatment Of Malignant Glioma; ERAS-801 Has Now Received ODD In Addition To FDA Fast Track Designation
Portfolio Pulse from Benzinga Newsdesk
Erasca's ERAS-801 has been granted FDA Orphan Drug Designation for the treatment of malignant glioma, including glioblastoma. The drug has also received FDA Fast Track Designation. Initial Phase 1 monotherapy data from the THUNDERBBOLT-1 trial is expected in H2 2023.
June 22, 2023 | 8:02 pm
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Erasca's ERAS-801 has been granted FDA Orphan Drug Designation for malignant glioma treatment and has received FDA Fast Track Designation. Phase 1 trial data is expected in H2 2023.
The FDA's Orphan Drug Designation and Fast Track Designation for ERAS-801 indicate the drug's potential in treating malignant glioma, a rare and aggressive cancer. This news is likely to have a positive impact on Erasca's stock price in the short term as it highlights the company's progress in developing a promising treatment.
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