Patient Gospel | New Drug Treatment for Three Types of Cancer

• by EVOMT
• 2017-06-05

　　FDA approved Zejula for three cancer treatments

　　On March 27, the US FDA approved Zejula for maintenance treatment in adult patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer (aimed at delaying cancer growth), and for patients with complete or partial tumor reduction (complete or partial remission, respectively) after platinum based chemotherapy

　　About these three types of cancer

　　Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer is a type of cancer that has tissue covering the ovary, or the inner or abdominal wall (peritoneum) of a tube. According to the National Cancer Institute of the United States, in 2017, more than 22000 women will be diagnosed with these cancers, and more than 14000 people will die from these diseases

　　The utility of Zejula

　　Zejula is a polyadenosine diphosphate ribose polymerase (PARP) inhibitor that can block an enzyme involved in repairing damaged DNA. By blocking this enzyme, DNA within cancer cells may not be repaired, leading to cancer cell death, possibly delaying or preventing tumor growth

　　The safety and effectiveness of Zejula was studied in a randomized trial involving 553 patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer who had previously received at least two platinum-based chemotherapy and experienced complete or partial remission after the most recent chemotherapy

　　Patients are first tested with an FDA approved diagnostic reagent to determine whether they carry a specific genetic mutation, a toxic or reproductive BRCA mutation. Clinical trials have tested the length of time (progression free survival) that patients with or without the mutation have been treating the tumor without growth

　　"Patients treated with Zejula and carrying reproductive BRCA mutations had a median progression free survival of 21 months, compared to 5.5 months for patients with the same disease treated with placebo. Patients treated with Zejula and not carrying reproductive BRCA mutations had a median progression free survival of 9.3 months, while patients with the same disease treated with placebo had a progression free survival of 3.9 months."

　　Side effects of Zejula

　　Common side effects of Zejula include decreased red blood cell levels (anemia), decreased platelet counts (thrombocytopenia), decreased white blood cell counts (neutropenia or leukopenia), palpitations, nausea, constipation, vomiting, abdominal pain/bloating (swelling), mucosal inflammation (mucositis), diarrhea, indigestion (food stagnation), dry mouth, fatigue, decreased appetite, urinary tract infection, liver problems (AST/ALT elevation), muscle pain (myalgia) Back pain, joint pain (arthralgia), headache, dizziness, unusual taste sensations (taste disorders), insomnia, anxiety, cold like symptoms (nasopharyngitis), breathing difficulties, cough, rash, and hypertension

　　Zejula is associated with serious risks, such as hypertension, severe elevated blood pressure (hypertensive crisis), bone marrow problems (myelodysplastic syndrome), a blood tumor (acute myeloid leukemia), and decreased bone marrow blood cell levels (myelosuppression). Pregnant women or lactating women should not use Zejula because the drug may have an impact on fetal development or newborn babies

　　FDA's evaluation of Zejula

　　"For patients who have achieved good remission after initial treatment, maintenance treatment is an important part of their cancer treatment plan," said Pazdur, MD, acting director of the Blood and Tumor Products Office and director of the FDA Cancer Optimization Center at the FDA Drug Evaluation and Research Center "Zejula provides patients with a new treatment option that can help delay the expected growth of these cancers, regardless of whether they have specific genetic mutations." FDA's treatment of Zejula

　　The FDA has granted fast-track review qualifications, priority review qualifications, and breakthrough therapy qualifications for this drug's marketing application. Zejula has also obtained orphan drug qualifications because it can be used to treat recurrent ovarian epithelial cancer. This qualification can provide incentives for applicants to help and encourage the development of drugs for rare diseases. Zejula was approved by Tesaro Corporation

　　Aiwo Overseas Diagnosis and Treatment

　　Aiwo provides all possibilities for patients. We have connected overseas high-quality doctor teams, including the Chinese American Doctor Group and the Japanese Proton Knife Team, to establish connections for domestic experts and provide smooth overseas medical services for domestic patients