Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

AstraZeneca’s and Merck’s Lynparza wins new breast cancer approval from FDA

By Brian Buntz | March 11, 2022

LynparzaThe poly(ADP-ribose) polymerase inhibitor Lynparza (olaparib) has become the first FDA-approved medicine targeting BRCA mutations in early breast cancer.

The drug was developed by AstraZeneca (NSDQ:AZN) and Merck & Co. (NYSE:MRK), which is known as MSD outside of the U.S.

Lynparza is already approved for a number of other indications. FDA approved the drug to treat advanced ovarian cancer in 2014. Indications followed for maintenance treatment of ovarian cancer and for germline BRCA-mutated metastatic breast cancer, pancreatic and advanced ovarian cancer. In 2020, FDA granted additional indications related to ovarian cancer and prostate cancer.

The most recent indication of Lynparza covers the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer.

The indication is limited to patients who have received prior chemotherapy before or after surgery.

In weighing the decision, FDA reviewed results from the OlympiA Phase3 study, which was also summarized in The New England Journal of Medicine.

Approximately 91% of U.S. breast cancer patients are diagnosed at an early stage.

BRCA mutations are present in 5-10% of patients.

Phase 3 trials are underway for olaparib in colorectal, endometrial, lung and squamous cell cancers.


Filed Under: Oncology
Tagged With: breast cancer, FDA, Lynparza, olaparib
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

Related Articles Read More >

Labcorp widens precision oncology toolkit, aims to speed drug-trial enrollment
AP Biosciences charts course for safer CD137 bispecifics with its T-cube platform
Cellares and UW-Madison partner to automate manufacturing for novel solid tumor CAR-T
Why smaller, simpler molecular glues are gaining attention in drug discovery
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE