Roche Holding AG’s RHHBY Perjeta (in combination with Herceptin and chemotherapy) received positive opinion from the EU Committee for Medicinal Products for Human Use (CHMP) as a neoadjuvant (pre-surgery) treatment of patients suffering from HER2-positive, locally advanced, inflammatory or early-stage breast cancer who are at a high risk of recurrence.
Roche stated that the CHMP’s recommendation for Perjeta was the first of its kind in the neoadjuvant setting based on encouraging pathological complete response in a phase II study (NeoSphere) on the candidate.
According to the World Health Organization and other sources, approximately 100,000 people in Europe are diagnosed with HER2-positive breast cancer each year. However, an abstract published in the SEER Cancer Statistics Review reveals that the majority of breast cancer cases can be diagnosed at an early stage of the disease. In this context, Roche emphasized the necessity to bring promising treatments to the market for patients diagnosed with early-stage breast cancer.
We note that the European Commission generally takes the CHMP’s recommendation into account during the approval process of a candidate. Given the CHMP’s positive opinion, we believe there is high chance for the drug to gain approval as the neoadjuvant treatment of HER2-positive locally advanced inflammatory or early-stage breast cancer.
We note that Perjeta is already approved as a neoadjuvant treatment for HER2-positive early-stage breast cancer in the U.S.
Meanwhile, Roche is conducting a phase III study (APHINITY) on Perjeta in the adjuvant (post-surgery) setting. The company expects data from this study to provide additional insight into Perjeta’s potential in the treatment of HER2-positive early-stage breast cancer.
Roche is one of the leading companies in the field of developing treatments for breast cancer. The company already has Herceptin, Perjeta and Kadcyla in its HER2-positive breast cancer franchise.
Roche carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care sector are Novo Nordisk A/S NVO, Bayer AG BAYRY and Abbott Laboratories ABT. All these stocks carry the same Zacks Rank as Roche.
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