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Because of the potential for serious adverse reactions from ZEJULA in breastfed infants, advise lactating women to not breastfeed during treatment with ZEJULA and for 1 month after receiving the final dose. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in 1.4% of patients receiving ZEJULA vs 1.1% of patients receiving placebo in Trial 1 (NOVA), and 0.9% of patients treated with ZEJULA in all clinical studies. GSK is enrolling a study testing Zejula alongside its PD-1 checkpoint inhibitor, dostarlimab, in ovarian cancer, again hoping to show a benefit for all ovarian cancer patients regardless of BRCA status.
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. In March 2017, Tesaro won approval for its drug Zejula to treat ovarian cancer. Some medicinal ingredients are susceptible to damage from heat, light and handling. BARCELONA—GlaxoSmithKline aimed high with its latest Zejula study: It wanted to prove the PARP inhibitor could fend off ovarian cancer in women who’d responded to one round of platinum chemotherapy—all women, not just those with the genetic mutation that makes tumors most susceptible to treatments in its class. Summary of Product Characteristics [EMA]: Zejula (niraparib) [PDF] Tesaro, Nov. 2017. Having struck two COVID-19 vaccine supply deals already, EU officials are in discussions with Novavax, as well.
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. In clinical studies, the most common adverse reactions (Grades 1-4) in ≥10% of patients included: thrombocytopenia (61%), anemia (50%), neutropenia (30%), leukopenia (17%), palpitations (10%), nausea (74%), constipation (40%), vomiting (34%), abdominal pain/distention (33%), mucositis/stomatitis (20%), diarrhea (20%), dyspepsia (18%), dry mouth (10%), fatigue/asthenia (57%), decreased appetite (25%), urinary tract infection (13%), aspartate aminotransferase (AST)/alanine aminotransferase (ALT) elevation (10%), myalgia (19%), back pain (18%), arthralgia (13%), headache (26%), dizziness (18%), dysgeusia (10%), insomnia (27%), anxiety (11%), nasopharyngitis (23%), dyspnea (20%), cough (16%), rash (21%) and hypertension (20%).
The Prima study hasn’t yet shown Zejula can help first-line patients live longer, but the trend in that direction is encouraging, Hoos said. How can you make the process of bringing your product to market less complex while also reducing costs? ZEJULA is a prescription medicine used for the: maintenance treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
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ZEJULA is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.