# AstraZeneca’s Lynparza approved in EU for early breast cancer

- Link: https://www.directorstalkinterviews.com/astrazenecas-lynparza-approved-in-eu-for-early-breast-cancer/4121075906
- Published: 2022-08-04T07:51:20+01:00
- Author: Amilia Stone

**[AstraZeneca plc](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON:AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l))
and MSD’s _Lynparza_ (olaparib) has been approved in the European Union (EU) as 
monotherapy or in combination with endocrine therapy for the adjuvant treatment 
of adult patients with germline BRCA1/2 mutations (gBRCAm), who have human epidermal
growth factor receptor 2 (HER2)-negative high-risk early breast cancer previously
treated with neoadjuvant or adjuvant chemotherapy.

This approval by the European Commission was based on results from the OlympiA Phase
III trial published in The New England Journal of Medicine in June 2021 and follows
the recommendation for approval in the EU by the Committee for Medicinal Products
for Human Use of _Lynparza_ in this setting.^(1) In the trial, _Lynparza_ demonstrated
a statistically significant and clinically meaningful improvement in invasive disease-
free survival (iDFS), reducing the risk of invasive breast cancer recurrences, new
cancers, or death by 42% versus placebo (based on a hazard ratio [HR] of 0.58; 99.5%
confidence interval [CI] 0.41-0.82; p<0.0001).

_Lynparza_ also demonstrated a statistically significant and clinically meaningful
improvement in overall survival (OS), reducing the risk of death by 32% versus placebo(
based on a HR of 0.68; 98.5% CI 0.47-0.97; p=0.009). The safety and tolerability
profile of _Lynparza_ in this trial was in line with that observed in prior clinical
trials.

Breast cancer is the most diagnosed cancer worldwide with an estimated 2.3 million
patients diagnosed in 2020.^(2) Approximately 90% of all breast cancer patients 
worldwide are diagnosed with early breast cancer and BRCA mutations are found in
approximately 10% of HER2-negative patients in Europe.^(3-5)

> **Professor Andrew Tutt, Global Chair of the OlympiA Phase III trial and Professor
> of Oncology at The Institute of Cancer Research, London and King’s College London,
> said**: “Today’s approval marks a new era of care in Europe for patients with 
> an inherited form of breast cancer. For patients with high-risk early-stage breast
> cancer, including those with germline BRCA mutations, recurrence rates remain 
> unacceptably high, with more than one in four of these patients seeing their cancer
> return following surgery and systemic treatment. Olaparib is the first PARP inhibitor
> to demonstrate improved overall survival for high-risk early-stage breast cancer
> patients with germline BRCA mutations and I am hopeful it will become a new standard
> of care.”

> **Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca,
> said:**
> “With this approval, _Lynparza_ is now the first and only PARP inhibitor available
> for patients with germline BRCA-mutated HER2-negative early breast cancer in Europe.
> We can now bring the benefits of _Lynparza_ to this earlier setting to help reduce
> the risk of life-threatening recurrence.”

> **Dr Eliav Barr, Senior Vice President, Head of Global Clinical Development and
> Chief Medical Officer, MSD Research Laboratories, said:** “Today’s approval offers
> patients with germline BRCA-mutated HER2-negative early-stage breast cancer a 
> new, much-needed treatment option. _Lynparza_ as adjuvant treatment can significantly
> reduce the risk of disease recurrence and death, reinforcing the importance of
> conducting germline BRCA testing as soon as possible after diagnosis.”

In March 2022, _Lynparza_ was approved in the US for the treatment of gBRCAm, HER2-
negative high-risk early breast cancer. _Lynparza_ is also approved in the US, EU,
Japan, and many other countries for the treatment of patients with gBRCAm, HER2-
negative, metastatic breast cancer previously treated with chemotherapy based on
results from the OlympiAD Phase III trial. In the EU, this indication also includes
patients with locally advanced breast cancer.

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