YONDELIS AND CAELYX COMBINATION APPROVED FOR RELAPSED PLATINUM SENSITIVE OVARIAN CANCER

EMEA extended indication of trabectedin in combination with pegylated liposomal doxorubicin to the treatment of patients with relapsed platinum-sensitive ovarian cancer

28.09.09

Category: Scientific News

Study results were first presented at the ESMO Congress in Stockholm

The European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) at its meeting on 21-24 September 2009, gave a positive opinion for applications for the extension of indication, adding new treatment option, for trabectedin, from Pharma Mar S.A. It extended the indication of trabectedin in combination with pegylated liposomal doxorubicin to the treatment of patients with relapsed platinum-sensitive ovarian cancer.

Results of the study entitled “A Randomized Phase III Study of Trabectedin with Pegylated Liposomal Doxorubicin (PLD) vs PLD in Relapsed, Recurrent Ovarian Cancer OVA-301” were presented by Dr B Monk during Presidential Symposium at the ESMO Congress in Stockholm (2008).

Trabectedin is currently indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents.

The EMEA has also completed a review on the risk of osteonecrosis of the jaw associated with the use of bisphosphonates. The CHMP was asked to give a scientific opinion on:

• the criteria that define osteonecrosis of the jaw related to bisphosphonates;
• how bisphosphonates may cause osteonecrosis of the jaw;
• whether the risk of osteonecrosis of the jaw is greater with some bisphosphonates or for some groups of patients;
• the measures that could be taken to minimise this risk.

The CHMP has concluded that there is an increased risk of osteonecrosis of the jaw in patients using these medicines. However, further studies should be carried out to better identify the factors that increase the risk and the measures needed to minimise it.

The review was carried out under Article 5(3) of Regulation (EC) 726/2004, opinion on any scientific matter concerning the evaluation of medicinal products for human use. Under this type of procedure the CHMP can give a scientific opinion on any matter concerning the evaluation of medicinal products for human use.

B. Monk: A Randomized Phase III Study of Trabectedin with Pegylated Liposomal Doxorubicin (PLD) vs PLD in Relapsed, Recurrent Ovarian Cancer OVA-301