U.S. Markets open in 1 hr 11 mins

Roche's Rozlytrek Gets Approval in Japan for Solid Tumors

Zacks Equity Research

Roche Holdings AG RHHBY announced that it has obtained approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Rozlytrek (entrectinib).

The drug has been approved for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumors.

Per Roche, Rozlytrek is the first tumour-agnostic medicine to be approved in Japan that targets NTRK gene fusions, which have been identified in a range of hard-to-treat solid tumour types, including pancreatic, thyroid, salivary gland, breast, colorectal and lung.

The approval was based on data from the phase II STARTRK-2 study, which showed that Rozlytrek shrunk tumours in more than half of patients with NTRK fusion-positive solid tumours across 10 different tumour types, including those with central nervous system metastases.

We remind investors that the drug is also under review in Japan for the treatment of patients with ROS1 fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Meanwhile, Rozlytrek has also been granted Priority Review by the FDA for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in adult and pediatric patients, who have either progressed following prior therapies or as an initial therapy when there are no acceptable standard therapies, and those with metastatic, ROS1 fusion-positive NSCLC. The drug has also been granted Priority Medicines (PRIME) designation by the European Medicines Agency (EMA).

The approval will strengthen Roche’s dominant position in the oncology market.

While the market for drugs for tumors and NSCLC is quite competitive, approval of new drugs bode well for Roche as it looks to diversify its portfolio in wake of stiff competition from biosimilars for key drugs such as Avastin, Rituxan and Herceptin from Novartis NVS and Amgen AMGN.

The stock has gained 10.8% in the year so far compared with the industry's 2.4% growth.


Last week, the FDA granted accelerated approval to Roche’s lymphoma drug, Polivy (polatuzumab vedotin-piiq), which targets CD79b that utilizes Seattle Genetics’ SGEN technology.

Zacks Rank

Roche currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) 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>>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Roche Holding AG (RHHBY) : Free Stock Analysis Report
Novartis AG (NVS) : Free Stock Analysis Report
Amgen Inc. (AMGN) : Free Stock Analysis Report
Seattle Genetics, Inc. (SGEN) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research