Aveo Oncology Gets Fast Track Designation for Carcinoma Treatment
20 September 2021 - 9:44PM
Dow Jones News
By Chris Wack
Aveo Oncology said the Food and Drug Administration has granted
fast track designation to ficlatuzumab for the treatment of
patients with relapsed or recurrent head and neck squamous cell
carcinoma.
The biopharmaceutical company said ficlatuzumab is its
investigational potent humanized immunoglobulin G1 monoclonal
antibody that targets hepatocyte growth factor.
In June, the company reported positive results from a randomized
confirmatory Phase 2 study of ficlatuzumab, alone or in combination
with cetuximab, an EGFR-targeted antibody, in patients with
metastatic head and neck squamous cell carcinoma who relapsed or
were refractory to prior immunotherapy, chemotherapy, and
cetuximab.
Aveo said a shortage of required key raw materials and
manufacturing supplies also used in Covid-19 vaccine manufacturing
has delayed the delivery of the clinical supply of ficlatuzumab.
The company sees the potential start date for a registrational
study in HPV negative head and neck squamous cell carcinoma in
2023, and expects to continue to discuss potential ficlatuzumab
pivotal study designs with the FDA and to continue ongoing
partnership dialogues.
Aveo Oncology shares were up 16% to $8 in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
September 20, 2021 07:29 ET (11:29 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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