FDA Grants Fast Track Designation to Pamrevlumab in Locally Advanced Unresectable Pancreatic Cancer

On March 1, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the anti–connective tissue growth factor (CTGF) antibody pamrevlumab for the treatment of patients with locally advanced unresectable pancreatic cancer. This follows review of the phase II clinical trial evaluating pamrevlumab in combination with gemcitabine and nanoparticle albumin–bound (nab)-paclitaxel (Abraxane).

“There are no approved treatment options for patients with locally advanced pancreatic cancer, who face a short life expectancy. We are encouraged by our phase II study results, where the combination of pamrevlumab with chemotherapy changed eligibility for surgical resection in a majority of treated patients who were previously not candidates for surgery,” said Peony Yu, MD, FibroGen’s Chief Medical Officer. “This designation is an important milestone for our pamrevlumab program and has the potential to speed our ability to advance pamrevlumab to patients.”

About Pamrevlumab

Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of CTGF, a common factor in fibrotic and proliferative disorders. Fibrosis is characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. In desmoplastic or fibrotic cancers such as pancreatic cancer, fibrous tissue promotes abnormal proliferation of tumor cells and associated stromal cells.

Pamrevlumab is advancing toward phase III clinical development for the treatment of idiopathic pulmonary fibrosis and pancreatic cancer and is currently in a phase II trial for Duchenne muscular dystrophy. In phase II clinical studies conducted to date, pamrevlumab has demonstrated a good safety and tolerability profile. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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