Submission based on data from the Phase III PRIMA clinical study that demonstrated clinically-meaningful outcomes of niraparib maintenance treatment in the first-line setting regardless of biomarker status - The application is being reviewed under the FDA’s Real-Time Oncology Review pilot program LONDON , Feb. 24, 2020 /PRNewswire/ -- GlaxoSmithKline plc today
| - Submission based on data from the Phase III PRIMA clinical study that demonstrated clinically-meaningful outcomes of niraparib maintenance treatment in the first-line setting regardless of biomarker status - The application is being reviewed under the FDA’s Real-Time Oncology Review pilot program LONDON, Feb. 24, 2020 /PRNewswire/ -- GlaxoSmithKline plc today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s submission of a supplemental New Drug Application (sNDA) seeking approval of Zejula (niraparib) as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status. The FDA is reviewing the sNDA under the Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The application is supported by data from the PRIMA study (ENGOT-OV26/GOG-3012), which demonstrated clinically-meaningful outcomes of niraparib treatment in the first-line maintenance setting.i Results from the PRIMA study were presented at the 2019 European Society for Medical Oncology Congress and simultaneously published in the New England Journal of Medicine. The PRIMA study enrolled women who responded to first-line treatment with platinum-based chemotherapy, including those at higher risk of disease progression, a population previously under-represented in first-line ovarian cancer studies. In the U.S., ovarian cancer impacts nearly 222,000 women annually,ii and approximately 85% of women with advanced ovarian cancer will see their disease return.iii With each recurrence, the time a woman may spend without her cancer progressing until the next recurrence gets shorter. Zejula is currently approved in the U.S. as a maintenance treatment for women with recurrent ovarian cancer who are in response to platinum-based chemotherapy regardless of BRCA mutation status. It is also approved as a treatment for women with advanced ovarian cancer, following three or more chemotherapy regimens. About PRIMA About Ovarian Cancer About Zejula (niraparib) Important Safety Information for ZEJULA Indications ZEJULA is indicated:
Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA. Important Safety Information Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in 14 patients (0.7%) out of 1902 patients treated with ZEJULA in clinical trials. The duration of therapy in patients who developed secondary MDS/cancer therapy-related AML varied from less than 2 months to greater than 4 years. These patients had received prior chemotherapy with platinum agents and/or other DNA-damaging agents including radiotherapy. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients receiving ZEJULA. Grade ≥3 thrombocytopenia, anemia and neutropenia were reported, respectively, in 29%, 25%, and 20% of patients receiving ZEJULA in NOVA, and 28%, 27%, and 13% of patients receiving ZEJULA in QUADRA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 3%, 1%, and 2% of patients in NOVA, and 4%, 2%, and 1% of patients in QUADRA. Do not start ZEJULA until patients have recovered from hematological toxicity caused by prior chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months, and periodically thereafter. If hematological toxicities do not resolve within 28 days following interruption, discontinue ZEJULA, and refer the patient to a hematologist for further investigations. Hypertension and hypertensive crisis have been reported in patients receiving ZEJULA. Grade 3-4 hypertension occurred in 9% of patients receiving ZEJULA vs 2% of patients receiving placebo in NOVA, with discontinuation occurring in <1% of patients. Grade 3-4 hypertension occurred in 5% of ZEJULA-treated patients in QUADRA, with discontinuation occurring in <0.2% of patients. Monitor blood pressure and heart rate at least weekly for the first two months, then monthly for the first year, and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Manage hypertension with antihypertensive medications and adjustment of the ZEJULA dose, if necessary. Embryo-Fetal Toxicity and Lactation: Based on its mechanism of action, ZEJULA can cause fetal harm. 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 of ZEJULA. 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. The most common adverse reactions in >10% of 830 patients who received ZEJULA in NOVA and QUADRA (n = 830) were nausea (70%), fatigue (58%), thrombocytopenia (56%), anemia (50%), vomiting (40%), constipation (38%), abdominal pain (35%), musculoskeletal pain (34%), decreased appetite (26%), neutropenia (25%), insomnia (23%), headache (22%), dyspnea (21%), diarrhea (18%), hypertension (16%), cough (15%), dizziness (13%), hypomagnesemia (13%), urinary tract infection (13%), acute kidney injury (13%), and white blood cell count decreased (11%). Common lab abnormalities (Grades 1-4) in ≥25% of patients who received ZEJULA in NOVA 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%). Common lab abnormalities (Grades 1-4) in ≥25% of patients who received ZEJULA in QUADRA included: decreased hemoglobin (83%), increased glucose (66%), decreased platelets (60%), decreased lymphocytes (57%), decreased leukocytes (53%), decreased magnesium (46%), increased alkaline phosphatase (40%), increased gamma glutamyl transferase (40%), increased creatinine (36%), decreased sodium (34%), decreased neutrophils (34%), increased aspartate aminotransferase (29%), and decreased albumin (27%). Please see accompanying Prescribing Information GSK in Oncology About GSK Cautionary statement regarding forward-looking statements Registered in England & Wales: Registered Office: i González-Martín A, Pothuri B, Vergote I, Christensen R, et al. Niraparib in patients with newly diagnosed advanced ovarian cancer. New England Journal of Medicine. 2019. doi:10.1056/NEJMoa1910962 SOURCE GlaxoSmithKline plc |
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