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)

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