Plus   Neg

Roche : CHMP Recommends EU Approval Of Phesgo For HER2-positive Breast Cancer

Roche (RHHBY) said Friday that the European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP has recommended the approval of Phesgo for the treatment of early and metastatic HER2-positive breast cancer.

The recommendation is based on results from the pivotal phase III FeDeriCa study, which showed that treatment with Phesgo produced non-inferior levels of Perjeta and Herceptin in the blood when compared to IV administration of the two medicines.

Phesgo is a fixed-dose combination of Perjeta or pertuzumab and Herceptin or trastuzumab with hyaluronidase, administered by subcutaneous injection in combination with intravenous (IV) chemotherapy.

The U.S. Food and Drug Administration recently expedited the approval of Phesgo for the treatment of early and metastatic HER2-positive breast cancer.

The Herceptin SC vial is approved for the treatment of HER2-positive breast cancer in more than 100 countries worldwide.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Best Buy said it is partnering Popsockets to bring products designed by teens from the company's community programs to its store shelves. The electronics retailer will sell the teen-designed PopGrips in its stores as part of its "Black History Month" campaign. The campaign is intended to celebrate and encourage young artists. Goldman Sachs Group Inc. (GS) on Tuesday reported a fourth-quarter profit that more than doubled from last year, reflecting a surge in investment banking revenues and lower provisions for bad loans. Net revenues for the quarter rose 18 percent. Both quarterly earnings per share and revenues topped analysts' expectations. U.S. holiday retail sales in 2020 were unexpectedly high compared to last year and came in significantly higher than the previous forecast, according to the National Retail Federation or NRF. Retail sales for the November-December 2020 holiday season grew 8.3 percent from the prior-year period to $789.4 billion. The figures exclude automobile dealers, gasoline stations and restaurants.
Follow RTT