Roche has applied for U.S. Food and Drug Administration approval for Kadcyla, a drug for post-surgical use in women with a form of early stage breast cancer who still show signs of disease after treatment with Herceptin and chemotherapy. The drug is already approved for patients with metastatic HER2-positive breast cancer.
The FDA will be reviewing Kadcyla under its Real-Time Oncology Review and Assessment Aid pilot program, which allows it to start analyzing trial data as soon as it becomes available. This will be Roche’s first med to undergo this process.
Kadcyla works by attaching Herceptin to a chemotherapy drug developed to interfere with cancer cell growth. Roche’s best-selling drug, Herceptin, has had its patent expire and the drugmaker is facing competition from rivals.
Read the Reuters report