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EMA's CHMP Backs Approval for Enhertu, Lynparza for Two Breast Cancer Indications

NEW YORK – The European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) on Monday recommended approval for AstraZeneca/Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) and AstraZeneca/Merck's Lynparza (olaparib) for two separate breast cancer indications.

The committee recommended Enhertu for the treatment of patients with unresectable or metastatic HER2-positive breast cancer who have received prior anti-HER2-based regimens. The recommendation was based on results from the DESTINY-Breast03 Phase III trial.

The study showed that Enhertu reduced the risk of disease progression or death by 72 percent versus Genentech's Kadcyla (trastuzumab emtansine). In the trial, 75.8 percent of patients treated with Enhertu were alive without disease progression at 12 months, compared to 34.1 percent of those on Kadcyla. Nearly 80 percent of patients in the Enhertu arm responded to treatment versus 34.2 percent of those in the Kadcyla arm.

In May, the US Food and Drug Administration approved Enhertu for the same indication as a second-line treatment for metastatic HER2-positive breast cancer. Last year, the drug was approved in Europe as a third-line treatment for patients with metastatic, HER2-positive breast cancer who have previously received two or more anti-HER2 treatments. It is also approved in the US in this third-line setting.

CHMP also recommended Lynparza as an adjuvant treatment for patients with early-stage, high-risk, HER2-negative breast cancer who have germline BRCA1/2 mutations and received prior neoadjuvant or adjuvant chemotherapy.

The positive opinion was based on results from the Phase III OlympiA trial, which showed Lynparza improved invasive disease-free survival by 42 percent compared to placebo. Earlier data from the trial also showed Lynparza improved overall survival compared to placebo.

In March, the FDA approved Lynparza for a similar indication, as an adjuvant treatment for early-stage high-risk HER2-negative breast cancer patients with germline BRCA1/2 mutations who have had their tumors surgically removed or previously treated with chemotherapy. The FDA simultaneously approved a Myriad Genetics BRACAnalysis companion diagnostic to identify patients for treatment.

Lynparza was previously approved in the US, EU, Japan, and other countries as a treatment for metastatic breast cancer patients with germline BRCA1/2 mutations who have received chemotherapy.