Roche RHHBY announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of immuno-oncology drug, Tecentriq, for yet another indication.
The CHMP recommended approval of Tecentriq in combination with Celgene Corporation’s CELG Abraxane for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC), whose tumours have PD-L1 expression (≥ 1%) and who have not received prior chemotherapy for metastatic disease.
The recommendation is based on data from the phase III IMpassion130 study, wherein Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death by 38% compared with nab-paclitaxel alone in patients who tested positive for PD-L1 expression on tumour-infiltrating immune cells (IC). The study will continue until the next planned analysis.
The European Commission generally takes the CHMP recommendation in consideration but is not bound by it. A decision from the commission is expected soon.
Roche has a strong presence in the oncology market. In particular, the company dominates the breast cancer space with strong demand for its HER2 franchise drugs. The HER2 franchise includes Herceptin, Perjeta and Kadcyla. Growth in Herceptin is being driven by increasing demand in the United States and Europe. A potential approval of Tecentriq for this indication will further boost the company’s franchise.
In March 2019, the FDA approved the drug for the same indication.
We remind investors that Tecentriq is approved in the United States, EU and/or countries, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and PD-L1-positive triple-negative breast cancer.
Tecentriq sales came in at CHF336 million in the first quarter of 2019, up 135% from the year-ago quarter. Label expansion of the drug for other indications should further boost sales.
Currently, Roche has seven ongoing phase III studies evaluating the drug in TNBC, including early and advanced stages of the disease.
Roche’s stock has gained 14% in the past six months compared with the industry’s growth of 3.2%.
Approval of new drugs and label expansion of 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.
Roche currently carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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