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Roche's (RHHBY) Tecentriq Gets FDA Approval for Breast Cancer

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Roche Holdings AG (RHHBY - Free Report) announced that the FDA has granted accelerated approval to immuno-oncology drug, Tecentriq in combination with Celgene Corporation’s (CELG - Free Report) Abraxane for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in patients whose tumors express PD-L1, as determined by an FDA-approved test.

The accelerated approval was based on encouraging data from the phase III IMpassion130 study, which showed that the combination significantly reduced the risk of disease worsening or death (PFS) by 40% compared with nab-paclitaxel alone.

The FDA generally grants conditional approval to a medicine that fills an unmet medical need for a serious or life-threatening disease or condition, under its Accelerated Approval Program. However, continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Per Roche, Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer.

Concurrently, Roche announced that the FDA also approved VENTANA PD-L1 (SP142) Assay2 as the first companion diagnostic to help in identifying TNBC patients who are eligible for treatment with cancer immunotherapy, Tecentriq plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]).

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 growing demand in both the United States and Europe. The approval of Tecentriq will further boost the company’s franchise.

Breast cancer is the one of the most common cancer among women worldwide. Per the American Cancer Society, approximately 271,000 people in the United States will be diagnosed with breast cancer with an estimated 42,000 deaths in 2019 alone.

Last week, the European Commission (EC) granted marketing authorization to Tecentriq in combination with Avastin, paclitaxel and carboplatin for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC). Meanwhile, Tecentriq is already approved in the European Union and the United States for previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC). The FDA had earlier approved Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with metastatic non-squamous NSCLC.

Tecentriq sales came in at CHF772 million in 2018, up 59% from 2017. Label expansion of the drug for other indications should further boost sales.

Roche’s stock has gained 11.2% in the past six months compared with the industry’s growth of 3%.

Approval of new drugs and label expansion of existing drugs bode well for the company as biosimilars pose stiff competition for some of its key drugs such as Avastin, Rituxan and Herceptin in the long term.  Novartis (NVS - Free Report) has already launched its bisomilar version of Rituxan/MabThera in Europe. Amgen (AMGN - Free Report) also obtained FDA approval for a biosimilar version of Avastin for the treatment of five types of cancers, including lung cancer, colorectal cancer, glioblastoma, renal cell carcinoma and cervix cancer.

Zacks Rank

Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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