The U.S. Food and Drug Administration has granted accelerated approval for a new drug targeting a tumor alteration called NRG1 gene fusion found in roughly 3% of patients with pancreatic adenocarcinoma, the most common type of pancreatic cancer. This approval underscores the promise of precision medicine – treatment based on the biology of a patient’s tumor – and reinforces how critical it is for all patients with this disease to receive biomarker testing of tumor tissue along with genetic testing for inherited mutations as soon as possible after diagnosis.
“The recent FDA accelerated approval of Bizengri is encouraging for people with pancreatic cancer whose tumor has an NRG1 fusion,” said PanCAN Chief Scientific and Medical Officer Anna Berkenblit, MD, MMSc. “This marks another treatment option for patients and highlights the power of a precision medicine approach and the importance of biomarker testing. This is an excellent precedent for rapid drug development in pancreatic cancer. Although only a small percent of pancreatic cancer patients have an NRG1 fusion, the responses seen with Bizengri are clinically meaningful, in the context of this difficult-to-treat cancer.”
BIZENGRI® is a targeted therapy. It has been granted accelerated approval by the FDA for a specific subset of patients diagnosed with pancreatic adenocarcinoma. This drug is available to patients whose tumor has an alteration called neuregulin 1 (NRG1) gene fusion whose cancer has worsened despite having gone through prior treatment. Roughly 3% of patients with pancreatic cancer have this alteration in their tumor, also referred to as NRG1 fusion-positive.
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