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