Pharma giant Roche has gained an EU approval for one of its breast cancer drugs and lost a US approval for another.
The EMA has recommended Herceptin (trastuzumab) for a licence extension that would see the drug used earlier in the progression of breast cancer.
In the same week, the FDA has revoked its approval for Roche’s Avastin (bevacizumab) as a treatment for breast cancer on the grounds that its benefits are outweighed by its side-effects.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has backed the use of Herceptin to treat patients with HER2-positive early breast cancer.
The drug is indicated for use in combination with neoadjuvant chemotherapy, followed by adjuvant Herceptin therapy.
The CHMP recommends the drug for use where the cancer is locally advanced or where tumours are larger than 2cm in diameter.
Herceptin is already approved in the EU for metastatic HER2-positive breast cancer. The drug works by reducing the body’s production of HER2, a growth factor that increases the aggressiveness of breast tumours.
The FDA has revoked its former approval for Roche’s breast cancer drug Avastin on the grounds that its benefits are modest and do not outweigh its side-effects. This follows the FDA’s decision in July to revoke Avastin’s approval in metastatic breast cancer.
The risks of Avastin include severe hypertension, bleeding, heart attack, heart failure and membrane perforations, the FDA said.
FDA Commissioner Margaret Hamburg commented: “After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit.”
Roche plans further studies to identify subgroups of advanced breast cancer patients who may benefit from treatment with Avastin, particularly in combination with paclitaxel.
Avastin will remain on the US market for other indications, including colon, lung, kidney and brain cancers.
The drug is currently approved in Europe for use in combination with paclitaxel to treat breast cancer.