FDA OK’s AZ & Merck’s Lynparza Plus Bevacizumab in HRD-Positive Ovarian Cancer

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #astrazeneca #fda #merck

PRICENTRIC BRIEF:

  • Lynparza (olaparib) in combination with bevacizumab (branded as Avastin) was approved by the US Food and Drug Administration (FDA) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability
  • To be selected for treatment with Lynparza, patients must take an FDA-approved companion diagnostic test
  • FDA approval was granted due to the biomarker subgroup analysis conducted in the Phase 3 PAOLA-1 trial in which Lynparza with bevacizumab maintenance treatment was shown to reduce the risk of disease progression or death by 67%, and the addition of Lynparza to bevacizumab improved progression-free survival (PFS)

THE DETAILS

WASHINGTON, D.C., The United States – Lynparza (olaparib) in combination with bevacizumab (branded as Avastin) was approved by the US Food and Drug Administration (FDA) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.

To be selected for treatment with Lynparza, patients must take an FDA-approved companion diagnostic test.

FDA approval was granted due to the biomarker subgroup analysis conducted in the Phase 3 PAOLA-1 trial in which Lynparza with bevacizumab maintenance treatment was shown to reduce the risk of disease progression or death by 67%, and the addition of Lynparza to bevacizumab improved progression-free survival (PFS) to a median of 37.2 months, versus 17.7 months with bevacizumab alone.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AZ, said, “This approval represents another milestone for Lynparza in patients with ovarian cancer. The median progression-free survival of more than three years offers new hope for more women to delay relapse in this difficult-to-treat disease. These results further establish that HRD-positive is a distinct subset of ovarian cancer, and HRD testing is now a critical component for the diagnosis and tailoring of treatment for women with advanced ovarian cancer.”

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories, commented, “Advances in understanding the role of biomarkers and PARP inhibition have fundamentally changed how physicians treat this aggressive type of cancer. Today’s approval based on the PAOLA-1 trial highlights the importance of HRD testing at diagnosis to identify those who may benefit from Lynparza in combination with bevacizumab as a 1st-line maintenance treatment.”

Approval in the EU, Japan, and other countries is currently being sought by AstraZeneca (AZ) and MSD for Lynparza plus bevacizumab. Also, Lynparza is being tested as monotherapy and in combination across many tumor types, including as a potential treatment of patients with germline BRCA-mutated high-risk HERs-negative primary breast cancer in the Phase 3 OlympiA trial.

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