16 September 2016 - Eleven medicines recommended for approval, including three medicines for cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eleven medicines for approval at its September meeting.

The CHMP recommended granting a conditional marketing authorisation for Lartruvo (olaratumab) for the treatment of adults with advanced soft tissue sarcoma. Lartruvo is to be used in combination with doxorubicin (a chemotherapy medicine) in patients with advanced soft tissue sarcoma for whom surgery or radiotherapy is not suitable, and who have not been previously treated with doxorubicin. Lartruvo was reviewed under EMA’s accelerated assessment mechanism and has an orphan designation. For more information, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Ibrance (palbociclib) for the treatment of women with locally-advanced or metastatic breast cancer. Ibrance is to be used to treat breast cancer that is hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)–negative. For more information, please see the press release in the grid below.

The CHMP recommended granting a conditional marketing authorisation for Ninlaro (ixazomib) for the treatment of multiple myeloma. This follows a re-examination of the Committee’s earlier negative opinion. Ninlaro is a new medicine that is taken orally to treat multiple myeloma, and it has an orphan designation.

Read EMA press release