FDA approves new targeted therapy for advanced pancreatic cancer
https://www.facingourrisk.org/XRAY/bizengri-for-NRG1-pancreatic-cancer
Full article: https://pmc.ncbi.nlm.nih.gov/articles/PMC11878197/
A new treatment called Bizengri has been approved by the FDA for patients with advanced or metastatic pancreatic cancer. This treatment targets pancreatic cancer or non-small cell lung cancers that have a rare tumor mutation called an NRG1 fusion. (Posted 7/24/25)
Questions To Ask Your Health Care Provider
- Have I had tumor testing?
- If I haven’t had tumor testing, can you order it for me?
- If I had tumor testing, what were the results and what do they mean?
- Did my tumor testing include RNA sequencing for changes like an NRG1 fusion?
- Is Bizengri a treatment option for me? Why or why not?
- What are the risks and benefits of Bizengri treatment? What are the possible side effects?
Open Clinical Trials
The following treatment studies are enrolling people diagnosed with pancreatic cancer.
- NCT07252232: Using the Drug Daraxonrasib in Surgically Removed Pancreatic Cancer (RASolute 304). This study is testing whether a new drug, Daraxonrasib (RMC-6236), helps prevent pancreatic cancer from returning after surgery and chemotherapy.
- NCT07491445: Comparing Daraxonrasib With or Without Chemotherapy to Chemotherapy Alone for First-Line Treatment of Metastatic Pancreatic Cancer (Rasolute 303). This study is testing a new targeted drug called daraxonrasib to see if it helps people with metastatic pancreatic cancer live longer or keep their cancer from growing longer than standard chemotherapy alone.
- NCT06411691: KRAS-Targeted Vaccine Combined With Targeted Therapy for Patients With Stage IV MMR-p Colorectal Cancer or Pancreatic Ductal Adenocarcinoma. This study will test the efficacy and immune response to a KRAS vaccine combined with immunotherapy for unresectable or metastatic mismatch repair-proficient (MMR-p) colorectal cancer (mCRC) or unresectable or metastatic MMR-p pancreatic ductal adenocarcinoma (PDAC) patients with measurable disease following first-line chemotherapy.
- NCT06782932: Comparing Neoadjuvant/​Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer. The purpose of this study is to determine the best dose of the drug AGEN2373 that is safe when given in combination with immunotherapy and Pancreatic GVAX vaccine and evaluate the safety and activity of balstilimab and AGEN2373 in combination with different vaccines in surgically resectable pancreatic adenocarcinoma.
- NCT04858334: Olaparib or Placebo in Patients with Surgically Removed Pancreatic Cancer who have a BRCA1, BRCA2 or PALB2 Mutation (APOLLO). This study compares the usual approach (observation) to treatment for one year with olaparib in patients with a BRCA1, BRCA2 or PALB2 mutation.
- NCT05932862: Study of a New InvestigationaI Inhibitor to Treat People with Advanced Solid Tumors. The study will test if an investigational treatment, XL309, is safe and works when used alone or in combination with a PARP inhibitor to treat people with advanced cancers, including pancreatic cancer.
- NCT04150042: SHARON: A Clinical Trial for Metastatic Cancer With an Inherited BRCA or PALB2 Mutation Using Chemotherapy and Patients’ Own Stem Cells. This study looks at whether melphalan, BCNU, vitamin B12b and vitamin C followed by autologous (self) bone marrow stem cell infusion is safe and effective for treating patients with advanced pancreatic cancer or stage 4, HER2-negative breast cancer for people with a BRCA1, BRCA2 or PALB2 inherited mutation.
Other clinical trials for people with pancreatic cancer can be found here.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.