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