With HER2 positive cancer believed to account for 20% to 25% of all breast-cancer cases, the FDA’s green light given to Perjeta, a new personalised medicine for previously-untreated HER2-positive metastatic breast cancer, comes as a boost to Roche and all affected by this form of breast cancer.
According to Pharma Times, “Perjeta (pertuzumab) is combined with Roche’s blockbuster anti-HER2 therapy Herceptin (trastuzumab) and the chemotherapy docetaxel. It is administered intravenously and works by targeting a different part of the HER-protein than Herceptin, resulting in further reduction in growth and survival of HER2-positive breast cancer cells.”
After a six-month review, it was found that people with previously untreated HER2-positive metastatic breast cancer who received the combination of Perjeta, Herceptin and docetaxel lived 6.1 months longer without their cancer getting worse compared to Herceptin plus docetaxel (ie median progression-free survival of 18.5 versus 12.4 months).
While these reports show positive results for Perjeta, the FDA has said Genentech is having a production problem that could affect future batches of the drug, and long-term supply. A Genentech spokeswoman said the company currently has enough supply to meet anticipated demand but confirmed the production problems. FDA said the company is experiencing a cell-growth issue. Future batches of drug will be approved on a case-by-case basis.
What do you think? A new breakthrough product or a miss?
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