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US FDA grants priority review to AstraZeneca’s sNDA for breast cancer therapy
Pharmaceutical-Business-Review
December 02, 2021
The US Food and Drug Administration (FDA) has granted priority review to AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) to treat BRCA-mutated (BRCAm) HER2-negative high-risk early breast cancer patients.
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Lynparza Granted Priority Review in the US for Breast Cancer
AmericanPharmaceuticalReview
December 01, 2021
AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) has been accepted and granted Priority Review in the US for the adjuvant treatment of patients with BRCA-mutated (BRCAm) HER2-negative high-risk early breast cancer who have...
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Lynparza shows promise in preventing cancer recurrence
pharmatimes
June 04, 2021
AstraZeneca and MSD's Lynparza (olaparib) has shown efficacy in preventing cancer recurrence in patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.
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AstraZeneca Announces First Quarter 2021 Results
americanpharmaceuticalreview
May 06, 2021
AstraZeneca delivered robust revenue growth of 15% (11% at CER) in the quarter to $7,320m; excluding the contribution from the pandemic COVID-19 vaccine, revenue growth increased by 11% (7% at CER) to $7,045m.
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NICE approves Lynparza plus Avastin via Cancer Drugs Fund
pharmatimes
March 19, 2021
The National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca/MSD’s Lynparza combined with Roche’s Avastin for certain patients with ovarian cancer via the Cancer Drugs Fund (CDF).
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NICE rejects AZ’s Lynparza for metastatic prostate cancer
pharmatimes
March 10, 2021
The UK’s National Institute for Health and Care Excellence’s (NICE) appraisal committee has chosen not to recommend AstraZeneca’s (AZ) PARP inhibitor Lynparza for BRCA-positive metastatic prostate cancer.
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IDMC Concluded Lynparza Trial Crossed Superiority Boundary for Invasive Disease-Free Survival
americanpharmaceuticalreview
February 20, 2021
The OlympiA Phase III trial for AstraZeneca and MSD’s Lynparza will move to early primary analysis and reporting following a recommendation from the Independent Data Monitoring Committee (IDMC).
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Lynparza crosses superiority boundary for invasive disease-free survival at interim analysis
europeanpharmaceuticalreview
February 19, 2021
The OlympiA trial will conduct its primary analysis early, after the Independent Data Monitoring Committee found it met its primary endpoint in BRCA mutated early breast cancer patients.
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LYNPARZA (olaparib) get three new approvals in Japan
expresspharma
December 29, 2020
Approvals in three types of cancer are based on the PAOLA-1, PROfound and POLO Phase 3 Trials.
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Lynparza scores two new EU approvals
pharmatimes
November 09, 2020
AstraZeneca and MSD's immunotherapy Lynparza (olaparib) has scored two new approvals in the European Union.