LYNPARZA® (Olaparib)

January 2nd, 2020

The FDA on December 27, 2019 approved LYNPARZA® for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma, as detected by an FDA-approved test, whose disease has not progressed on at least 16 weeks of a first-line Platinum-based chemotherapy regimen. The FDA also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) as a companion diagnostic for the selection of patients with pancreatic cancer for treatment with LYNPARZA®, based upon the identification of deleterious or suspected deleterious germline mutations in BRCA1 or BRCA2 genes. LYNPARZA® is a product of AstraZeneca Pharmaceuticals LP.


LYNPARZA® (Olaparib)

December 27th, 2018

The FDA on December 19, 2018 approved LYNPARZA® for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in Complete or Partial Response to first-line platinum-based chemotherapy. LYNPARZA® is a product of AstraZeneca Pharmaceuticals LP.


LYNPARZA® (Olaparib)

January 19th, 2018

The FDA on January 12, 2018, granted regular approval to LYNPARZA® tablets, a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer, who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting. LYNPARZA® is a product of AstraZeneca Pharmaceuticals LP.


LYNPARZA® (Olaparib)

October 4th, 2017

The FDA on August 17, 2017 granted regular approval to LYNPARZA® tablets 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. LYNPARZA® is a product of AstraZeneca.


LYNPARZA® (Olaparib)

January 2nd, 2015

The FDA on December 19, 2014 approved LYNPARZA® capsules as monotherapy for the treatment of patients with deleterious or suspected deleterious germline BRCA mutated (gBRCAm) (as detected by an FDA-approved test) advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy. Concurrent with this action, FDA approved the BRACAnalysis CDx® (Myriad Genetics) for the qualitative detection and classification of variants in the BRCA1 and BRCA2 genes. LYNPARZA® capsules is a product of AstraZeneca Pharmaceuticals LP.