ALXO - ALX Oncology stock rises on FDA fast track status for evorpacept to treat head/neck cancer
- The U.S. Food and Drug Administration (FDA) granted fast track designation to ALX Oncology's ( NASDAQ: ALXO ) evorpacept, in combination with Merck's ( NYSE: MRK ) Keytruda (pembrolizumab), as a first-line treatment of adult patients with PD-L1 positive advanced head and neck squamous cell carcinoma.
- The company said the FDA decision was backed by data from a phase 1 trial called ASPEN-01.
- "The FDA’s Fast Track designation for the first-line treatment of HNSCC with evorpacept in combination with pembrolizumab builds upon evorpacept’s prior Fast Track designation in the first-line HNSCC population in combination with pembrolizumab and standard chemotherapy highlighting the potential clinical utility of evorpacept in this difficult-to-treat disease," said ALX Chief Medical Officer Sophia Randolph.
- ALXO +4.96% to $10.16 premarket Aug. 1
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ALX Oncology stock rises on FDA fast track status for evorpacept to treat head/neck cancer