The U.S. Food and Drug Administration on Monday approved Roche Holding AG’s combination therapy for a form of advanced breast cancer that has spread to other parts of the body.
The therapy, Phesgo, was approved for patients with HER2-positive breast cancer and comes with a boxed warning flagging risks of potential heart failure, foetal harm and lung toxicity.
The injectable combination treatment includes Roche’s breast cancer therapies Perjeta and Herceptin along with hyaluronidase, which is used to enhance the absorption of the drugs.
The therapy works by targeting the HER2 protein, a major trigger of uncontrolled cell growth in 20% of breast cancers. Roche has been a pioneer in the therapeutic area with its best-seller, Herceptin.
The therapy, which is initially used in combination with chemotherapy, can continue to be administered at home by a qualified healthcare professional after the patient is finished with the chemotherapy regimen.
The most common side-effects for patients taking Phesgo were alopecia, nausea, diarrhoea, anaemia and asthenia, the company said.
Roche's combo therapy for advanced breast cancer gets U.S. FDA approval