Roche (RHHBY - Free Report) announced that its breast cancer drug, Kadcyla significantly reduced the risk of disease recurrence by 50% as adjuvant (after surgery) therapy in phase III KATHERINE study compared to its other breast cancer drug, Herceptin. The late-stage KATHERINE study compared Kadcyla to Herceptin for risk of disease recurrence or death in HER2-positive early breast cancer patients with residual disease following a neoadjuvant (before surgery) therapy.
Back in October, Roche announced that the study had met its primary endpoint of reduction in disease recurrence
The latest data from the study also showed that on treatment with Kadcyla the disease did not recur in 88.3% of the patients treated with Kadcyla at three years versus 77% for Herceptin.
Kadcyla, an antibody-drug conjugate, is approved as monotherapy in second-line setting for treating metastatic breast cancer in patients who have received treatment with Herceptin or/and taxane since 2013.
The company is planning to submit regulatory applications for label expansion of Kadcyla in early breast cancer patients based on the study data. A potential approval will boost the prospects of the drug as it will expand the patient population.
Roche’s stock has gained 1.2% so far this year compared with the industry's growth of 9.1%.
We remind investors that Roche has licensed technology for Kadcyla under an agreement with ImmunoGen, Inc. (IMGN - Free Report) . Kadcyla has recorded year-over-year growth of 8% in its sales so far this year and may achieve blockbuster status by the year end.
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 both the United States and Europe due to longer treatment duration.
Although new drugs are performing well, Roche’s legacy drugs like Avastin, Herceptin and Rituxan are facing competition from biosimilars. Novartis (NVS - Free Report) has already launched its biosimilar version of Rituxan/MabThera in Europe. The FDA approved Teva Pharmaceutical’s (TEVA - Free Report) Rituxan biosimilar, Truxima, last month.
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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