Editors’ pickHealth

EC Approves Olaparib for BRCA Breast Cancer

The European Commission approved last week the oral therapy olaparib (Lynparza, AstraZeneca/MSD) for the treatment of locally advanced or metastatic breast cancer in patients who have germline BRCA1/2 mutations (gBRCAm) and are human epidermal growth factor receptor 2 (HER2) negative.

The new indication has additional stipulations.

One, patients should have been previously treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting — unless they were unsuitable for these chemotherapies. Two, patients with hormone receptor (HR) positive disease should have progressed on or after prior endocrine therapy — unless they were unsuitable for that therapy.

Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes.

The new approval was based on efficacy and safety data from the randomized, open-label, phase 3 OlympiAD trial that compared olaparib (300 mg twice daily) against physician’s choice of chemotherapy (capecitabine [Xeloda, Hoffmann-La Roche]), eribulin [Halaven, Eisai], or vinorelbine [Navelbine, Pierre Fabre]).

Patients in the olaparib group (n = 205) had a median progression-free survival (PFS) of 7 months versus 4.2 months for the chemotherapy group (n = 97) (hazard ratio [HR], 0.58; P = .0009). PFS was the primary endpoint. Additionally, the olaparib group had an objective response rate (ORR) of 52% versus 23% in the chemotherapy group.

The most common adverse reactions (≥ 20%) among study patients who received olaparib were nausea (58%), anemia (40%), fatigue (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).

Also, 5% of patients in the olaparib group discontinued treatment versus 8% in the chemotherapy group.

“With this approval, [olaparib] provides patients throughout the EU with a targeted and oral chemotherapy-free treatment option for a difficult-to-treat cancer,” said Dave Fredrickson, executive vice president, AstraZeneca, in a company press statement. He added: “It also reinforces the importance of testing for biomarkers including BRCA, HR, and HER2 expression, helping physicians to make the most informed treatment decisions for patients.”

Follow Medscape’s Nick Mulcahy on Twitter. For more from Medscape Oncology, follow us on Twitter

Source link

Tags
Back to top button
close
Thanks !

Thanks for sharing this, you are awesome !

Pin It on Pinterest

Share This

Share this post with your friends!