European advisors have recommended that Pharmion’s thalidomide-based cancer drug receive a full green light for the treatment of multiple myeloma, a rare cancer of the bone marrow.

Thalidomide caused a stir in the 1970s after it was found that extensive use in pregnant women during the 50s and 60s as a treatment for morning sickness led to the birth of babies with malformed, short or absent limbs, and it was promptly taken off the market.

But the European Medicines Agency’s Committee for Medicinal Products for Human Use says the benefits of Thalidomide Pharmion, in combination with melphalan and prednisone, outweigh its risks for the first-line treatment of multiple myeloma in patients over 65 years of age or who are unable to take high-dose chemotherapy.

Its recommendation is based findings from clinical trials which showed that adding Thalidomide Pharmion to a regimen of melphalan and prednisone can boost survival time by about 18 months in newly-diagnosed patients over 65 years of age, compared to those taking standard chemotherapy.

Because of its high-risk to unborn babies, the Committee says it has approved a risk management plan designed to prevent pregnancies in women being treated with thalidomide. Furthermore, if the drug receives the final nod from European regulators, it will only be available via prescription, with warnings clearly printed on the boxes.

Multiple myeloma is the second most common cancer of the blood, affecting around 82,000 people in the European Union alone, with 25,000 newly diagnosed each year. Commenting on the recommendation, Patrick Mahaffy, Pharmion's president and chief executive officer, said the “return of Thalidomide to Europe as an approved therapy represents a significant step toward the safe distribution of this important and widely used drug for patients with multiple myeloma.”

Revlimid turned down
Meanwhile, Pharmion’s parent company Celgene said the CHMP had not been so kind to its own thalidomide-based drug Revlimid (lenalidomide), issuing a ‘thumbs down’ for its use in transfusion-dependent anaemia in some patients with myelodysplastic syndromes.

The company said that, while the CHMP conceded that the drug is effective in patients with MDS, it was not convinced available data “were sufficient to assure safety”.

In June last year, Revlimid was allowed onto the European market for the treatment of patients with multiple myeloma who have received at least one prior therapy.