Roche's Tecentriq Combo Gets EU Nod for Critical Breast Cancer

Roche Holdings AG RHHBY announced that the European Commission (EC) has approved its immuno-oncology drug Tecentriq in combination with Celgene’s CELG chemotherapy drug Abraxane for the treatment of adult patients with unresectable locally advanced/metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1, having not received a prior chemotherapy for metastatic disease.

The approval was based on data from the phase III IMpassion130 study, which showed that the combo of Tecentriq + Abraxane significantly reduced the risk of disease worsening or death (PFS) by 38% compared to nab-paclitaxel alone. Moreover, progression-free survival (PFS) results demonstrated a statistically significant benefit for the combination.

Per the company, Tecentriq combination is the first cancer immunotherapy regimen to be approved for triple-negative breast cancer in Europe. Notably, in July 2019, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of the Tecentriq combo for the given indication.

Tecentriq (for multiple indications) recorded significant growth in sales during the first half of 2019. Higher sales were mainly witnessed in the United States, Europe and Japan. This approval of Tecentriq for the above-mentioned indication will further boost the drugs’ sales.

Earlier this March, the FDA granted an accelerated approval for the same combo of Tecentriq + Abraxane for the same indication.

Meanwhile, last week, Roche’s subsidiary Chugai obtained a regulatory nod for Tecentriq in Japan for the treatment of extensive-stage small cell lung cancer (SCLC).

Shares of Roche have rallied 10.4% so far this year against the industry’s decrease of 2.1%.

Currently, Roche has seven ongoing phase III studies evaluating Tecentriq for TNBC including the early and advanced stages of the disease.

Roche has a strong presence in the oncology market. Particularly, it dominates the breast cancer space with solid demand for its HER2 franchise drugs. The HER2 franchise includes Herceptin, Perjeta and Kadcyla. Growth in Herceptin is being driven by increasing demand across the United States and Europe.

Approval of new drugs and label expansion of the existing drugs bode well for the company and should offset the adverse impact of biosimilar competition for some of its key drugs, such as Avastin, Rituxan and Herceptin from the likes of Novartis NVS and Amgen AMGN.

In a separate press release, Roche announced that the EC has also approved VENTANA PD-L1 (SP142) Assay as the first companion diagnostic to help identify the TNBC patients, who are eligible for treatment with cancer immunotherapy, and Tecentriq plus chemotherapy.

Zacks Rank

Roche currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Breakout Biotech Stocks with Triple-Digit Profit Potential

The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.

Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +98%, +119% and +164% in as little as 1 month. The stocks in this report could perform even better.

See these 7 breakthrough stocks now>>

Click to get this free report

Novartis AG (NVS): Free Stock Analysis Report

Roche Holding AG (RHHBY): Free Stock Analysis Report

Celgene Corporation (CELG): Free Stock Analysis Report

Amgen Inc. (AMGN): Free Stock Analysis Report

To read this article on click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Other Topics


Latest Markets Videos


    Zacks is the leading investment research firm focusing on stock research, analysis and recommendations. In 1978, our founder discovered the power of earnings estimate revisions to enable profitable investment decisions. Today, that discovery is still the heart of the Zacks Rank. A wealth of resources for individual investors is available at

    Learn More