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LYNPARZA® (olaparib) Approved by FDA as First-Line Maintenance Treatment of Germline

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved LYNPARZA for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of […]

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FDA approves ENHERTU® for treatment of adult patients with unresectable or metastatic Her2 positive breast cancer.

Daiichi Sankyo and AstraZeneca announced that the US Food and Drug Administration (FDA) approved ENHERTU® (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. This indication is approved under accelerated approval based on tumor response […]

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Pfizer announces new safety information added to the labeling for all CDK4/6 inhibitors, including IBRANCE.

IBRANCE (palbociclib) 125 mg capsules is indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men, or fulvestrant in patients with disease progression following endocrine therapy The 5.2 Warnings […]

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