Two further indications of Prolia approved in US

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The FDA has approved Amgen’s osteoporosis drug Prolia for the treatment of bone loss associated with certain chemotherapy.

The medicine is the first for cancer treatment-induced bone loss, now indicated for women receiving adjuvant aromatase inhibitor therapy for breast cancer and men with prostate cancer who are being treated with hormone therapy.

The denosumab drug is known to reduce fracture risks in breast cancer patients taking drugs that halt oestrogen production and prostate cancer patients treated with androgen-deprivation therapies.

Matthew Smith, Director of the Genitourinary Malignancies Programme at Massachusetts General Hospital Cancer Center in Boston, said: “Bone loss and fractures are recognised adverse effects of hormone ablation therapies but we have not had an approved treatment option to prevent these problems for our patients”.

Prolia was previously approved in 2010, intended to be used in post-menopausal women with osteoporosis who were at increased risk of fractures.

Both therapies reduce hormone levels, leading to increased risk of bone loss and fracture.

Denosumab is also the active ingredient in Amgen’s Xvega, which is designed to prevent fractures in patients with cancer that has spread to the bone.

Denosumab is the first in a new class of medicines that blocks proteins that activate bone-destroying cells called osteoclasts.