Summary of Product Characteristics [EMA]: Zejula (niraparib) [PDF] Tesaro, Nov. 2017. Cold chain shipping. A 50% reduction in risk for wild-type BRCA patients whose tumors had homologous recombination deficiencies (HRD), for one, and 32% for women with neither BRCA mutations nor HRD. All patients had received prior chemotherapy with platinum and some had also received other DNA damaging agents and radiotherapy. Enclose phrases in quotes. NRPWCNT200043 April 2020 ©2020 GSK or licensor. ZEJULA is the first and only once-daily PARP inhibitor used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy. This Whitepaper identifies opportunities to simplify channel strategies for biopharma companies, their customers and patients. Right now, the five-year survival rate for ovarian cancer is less than 50%, GSK noted in its data release. (GSK), Reducing the Complexity and Costs of Channel Planning and Logistics. “All can benefit.”, RELATED: GSK's Zejula racks up first-line maintenance win in ovarian cancer, even in non-BRCA patients. for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months after receiving their final dose. ESMO: Glaxo sizes up AZ, Merck challenge with Zejula's all-comers ovarian cancer win, GSK's Zejula racks up first-line maintenance win in ovarian cancer, even in non-BRCA patients, GlaxoSmithKline, looking to pump up in new favorite oncology, buys Tesaro for $5.1B, EU progressing in COVID-19 vaccine talks with Novavax: report, European pharmas eye pricing changes from U.S. elections, Sun Pharma recalls metformin after carcinogen test. Reproduction in whole or part is prohibited. Manage hypertension with antihypertensive medications and adjustment of the ZEJULA dose, if necessary. Find out more about how we use your information in our Privacy Policy and Cookie Policy. With U.S. presidential and congressional campaigns in full swing, it’s not just Americans anxiously awaiting the results of the upcoming elections. That’s a distinction its rivals in the competitive PARP inhibitor class can’t boast, at least on the monotherapy side; archrival Lynparza from AstraZeneca and Merck put up data at ESMO Saturday showing the drug combined with Avastin could keep cancer at bay in all-comers, too.

for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy. You are using an unsupported browser.Some features of this site may not function properly. In March 2017, Tesaro won approval for its drug Zejula to treat ovarian cancer. Common lab abnormalities (Grades 1-4) in ≥25% of patients included: decrease in hemoglobin (85%), decrease in platelet count (72%), decrease in white blood cell count (66%), decrease in absolute neutrophil count (53%), increase in AST (36%) and increase in ALT (28%). You can change your choices at any time by visiting Your Privacy Controls. The drug, which GSK acquired in its $5.1 billion Tesaro buyout, stopped cancer in its tracks, cutting the risk of disease progression or death by 38% across the spectrum of ovarian cancer patients, and by more than that in a key patient group, according to data released here at the European Society for Medical Oncology meeting. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, in 3%, 1%, and 2% of patients, respectively. exclude terms. For optimal user experience, please view this site in Chrome, Firefox, Safari, or Edge. On May 31, 2017, it was reported that Tesaro Inc. was exploring a sale. Zejula, by the GSK company Tesaro, is a PARP inhibitor that works by interfering with cancer cells' ability to repair their DNA, thereby causing their death.

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Discontinue ZEJULA if MDS/AML is confirmed.