EU Approves Merck's Keytruda Combination For Early-stage Triple-negative Breast Cancer

The European Commission has approved Keytruda, Merck's anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced or early-stage triple-negative breast cancer or TNBC at high risk of recurrence, Merck & Co Inc. (MRK) said in a statement on Tuesday.

The approval was based on results from the pivotal Phase 3 KEYNOTE-522 trial, in which Keytruda in combination with chemotherapy before surgery and continued as a single agent after surgery prolonged event-free survival (EFS), reducing the risk of EFS events or death by 37% compared to neoadjuvant chemotherapy alone in this patient population. Median follow-up time for all patients was 37.8 months.

The safety of Keytruda plus chemotherapy has been evaluated in 3,123 patients across tumor types. The incidence of Grade 3-5 adverse reactions in patients with TNBC was 80% for KEYTRUDA plus chemotherapy and 77% for chemotherapy.

The approval allows marketing of the Keytruda regimen in all 27 EU member states plus Iceland, Lichtenstein, Norway and Northern Ireland. This is the second indication for Keytruda in breast cancer in Europe.

In October 2021, Keytruda plus chemotherapy was approved for the first-line treatment of certain patients with locally recurrent unresectable or metastatic TNBC.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Specialty athletic retailer Foot Locker, Inc. reported Friday a second-quarter net profit that plunged from last year, hurt by a sales decline amid markdowns. Quarterly sales met Street estimates. The company also trimmed it adjusted earnings and sales growth guidance for the full-year 2022. Google's hundreds of employees have signed a petition sent to executives demanding extension of abortion care benefits to contract workers. The workers also called to halt donations given to anti-abortion politicians and to expand travel benefits. The petition, circulated by the Alphabet Workers Union, has been signed by over 650 employees at Google's parent company Alphabet Inc. Apple Inc. has released an emergency security update noting that some of its iPhones, iPads and Macs had certain vulnerabilities. The tech major said the flaws potentially allow full admin access to devices. The models affected by the issue include iPhone 6S and later models, several models of the newer iPads, and Mac computers running macOS Monterey and above. The flaws also affect the iPod Touch
Follow RTT