AstraZeneca, Merck breast cancer treatment lands FDA approval

By Jenni Spinner

- Last updated on GMT

(Klaus Vedfelt/iStock via Getty Images Plus)
(Klaus Vedfelt/iStock via Getty Images Plus)

Related tags Astrazeneca Merck & co MSD Breast cancer Fda FDA approval

The agency has approved Lynparza for use in the US as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.

AstraZeneca and Merck and Co. (known as MSD outside the US and Canada) have announced that Lynparza (olaparib) has been approved in the US for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer. The treatment is indicated for patients within that grouping who have already been treated with chemotherapy either before or after surgery.

The US Food and Drug Administration (FDA) approval reportedly was based upon results from the OlympiA Phase III trial presented during the 2021 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine. Breast cancer is the most diagnosed cancer worldwide with an estimated 2.3m patients diagnosed in 2020; according to​, this year in the US alone, an estimated 287,850 new cases of invasive breast cancer will be diagnosed, in addition to 51,400 new cases of non-invasive (in situ) breast cancer.

To learn more about the treatment and what its approval might mean for breast cancer patients, Outsourcing-Pharma connected with Camille Hertzka, vice president and head of oncology for US medical with AstraZeneca.

OSP: Could you please share your perspective on any notable developments/advancements we’ve seen in treating this variety of breast cancer in recent years?

CH: Overall, outcomes for people with breast cancer have significantly improved in the last 30 years. However, even with early diagnosis, approximately 30% of patients will go on to develop disease recurrence where a cure is no longer an option. Preventing cancer from coming back remains one of the greatest challenges in the treatment of early breast cancer – especially for people with high-risk disease.

Almost 91% of all breast cancer patients in the US are diagnosed at an early stage of disease and BRCA mutations are found in approximately 5-10% of patients. Those with germline BRCA mutations (gBRCAm) tend to have more aggressive disease and may be at a significantly higher risk for disease recurrence of breast cancer and an increased risk of other types of cancer – such as ovarian cancer.

With the approval of Lynparza in gBRCAm, HER2-negative high-risk early breast cancer, we are able to do more to increase the potential for people to live longer without their cancer returning.

OSP: Could you please elaborate on what makes this approval particularly good news for high-risk, early breast cancer patients?

Camille Hertzka, vice president and head of oncology for US medical, AstraZeneca

CH: On average, women and men with gBRCAm breast cancer tend to be younger at diagnosis – highlighting the urgency for early intervention to manage their disease. In the OlympiA trial, the median age of patients enrolled was 42; these patients are often in the prime of their lives with a strong focus on career, family, and other interests. People with gBRCAm early breast cancer tend to have more aggressive disease and may be at a significantly higher risk for disease recurrence compared to people without a gBRCAm.

In OlympiA, Lynparza significantly reduced the risk of invasive breast cancer recurrences, second cancers, or death in gBRCAm high-risk HER2-negative early breast cancer by 42% versus placebo. Updated results showed Lynparza also reduced the risk of death by 32% versus placebo, a statistically significant improvement in overall survival (OS).

These results are meaningful for patients and the doctors who treat them. OlympiA is the first global trial of a PARP inhibitor to demonstrate a survival benefit in early breast cancer.

The approval of Lynparza in this setting brings a new, personalized oral treatment option to people living with early breast cancer in the US with a germline BRCA1 or BRCA2 mutation. While historically germline BRCA mutation status has informed cancer risk and risk-reducing surgical options, this approval provides eligible patients with gBRCAm early breast cancer with an oral treatment option in the adjuvant setting that significantly extends survival and reduces the risk of recurrence.

OSP: Can you tell us when you expect this treatment to be available for administering to patients?

CH: Following FDA approval on March 11, Lynparza is available to patients with gBRCAm HER2-negative high-risk early breast cancer. Lynparza is already approved for other indications as well. Patients are to be selected for treatment based on an FDA-approved companion diagnostic test for Lynparza.

Germline BRCA mutations are actionable biomarkers and testing for these mutations at diagnosis is an important step that can help inform treatment decisions – including identifying patients who may be eligible for Lynparza in this setting.

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