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FDA grants fast track designation to pamrevlumab for pancreatic cancer
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The FDA granted fast track designation to pamrevlumab for the treatment of patients with locally advanced unresectable pancreatic cancer, according to a manufacturer-issued press release.
Pamrevlumab (FibroGen) — a connective tissue growth factor inhibitor — is being studied in idiopathic pulmonary fibrosis and Duchenne muscular dystrophy, in addition to pancreatic cancer.
The FDA based this designation on review of a phase 2 trial of pamrevlumab in combination with gemcitabine and nab-paclitaxel among patients with locally advanced unresectable pancreatic cancer. Results showed pamrevlumab plus chemotherapy changed most patients’ eligibility status for surgical resection.
“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 2 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,” Peony Yu, MD, FibroGen’s chief medical officer, said in the press release. “This designation is an important milestone for our pamrevlumab program and has the potential to speed our ability to advance pamrevlumab to patients.”