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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.”
Here, PanCAN answers questions related to this new treatment option.
What is BIZENGRI (zenocutuzumab-zbco)?
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.
What does this FDA approval mean?
The FDA has granted accelerated approval for BIZENGRI for this subset of pancreatic cancer patients and for patients with metastatic non-small cell lung cancer (NSCLC) with the same characteristics: NRG1 fusion-positive and whose cancer has worsened despite having gone through prior treatment. This represents the first FDA approval of a systemic therapy for patients with pancreatic adenocarcinoma or NSCLC with an NRG1 gene fusion.
BIZENGRI was approved using the FDA Accelerated Approval process – which is meant to fast-track drugs that are reasonably likely to show clinical benefit, such as shrinking a tumor. This means that the drug can be prescribed, but researchers must still continue to study the drug to make sure it is safe and effective in order to remain approved.
What is the survival benefit for patients with pancreatic cancer?
The study from the oncology company Merus included 30 patients with NRG1 gene fusion-positive pancreatic cancer. Forty percent of those patients had their tumors shrink (called responses) and two-thirds of patients with responses had responses lasting at least six months.
I am a patient interested in BIZENGRI. What should I do?
People diagnosed with pancreatic cancer should talk to their healthcare team about this treatment option. The first step to determine if a patient’s cancer is NRG1 fusion-positive – or if it harbors any other actionable alterations – is biomarker testing of their tumor tissue. PanCAN’s Know Your TumorⓇ precision medicine service offers this testing to eligible patients. Many major hospitals and cancer centers now also offer genetic and biomarker testing. Here are some additional action steps to consider:
- Ask your doctor if biomarker testing has been performed on your tumor and if they have used the results to make a treatment decision.
- Contact PanCAN Patient Services. Our expert Case Managers can help explain different types of testing.
- If you’ve already had biomarker or genetic testing, PanCAN Patient Services can help you understand your results and give you information on treatment options, including clinical trials.
What are the side effects of BIZENGRI?
The most common side effects reported in a press release from Merus include the following: diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, dyspnea, rash, constipation, vomiting, abdominal pain and edema.
Does insurance cover this treatment?
FDA approval means this drug combination is safe and effective, and although the FDA does not decide what is covered by insurance, when a drug gets FDA approval Medicare and Medicaid will usually cover it. Coverage for chemotherapy drugs will vary based on the specific plan and insurance company a person uses.
Contact PanCAN Patient Services for more information on financial assistance programs for those experiencing or anticipating cost-related barriers to care.
Why is this news important?
The potential of precision medicine is clear. We know that patients with pancreatic cancer who receive treatment based on their biology can live longer. With every drug approval, we are providing more options to more patients diagnosed with this challenging disease.
The approval of BIZENGRI adds to a wave of recent drug approvals targeting alterations present in pancreatic cancer, including nine since 2019. We need continued investment in research and advocacy for federal funding to continue this progress.
