Roche is closing on a big new indication for its cancer drug Avastin in Europe after the Committee for Medicinal Products for Human Use (CHMP) said it should be approved for platinum-resistant recurrent ovarian cancer.
Avastin (bevacizumab) becomes the first biologic medicine to be recommended for treating platinum-resistant recurrent ovarian cancer, the most challenging form of the disease to treat with only a quarter of patients surviving beyond five years.
The CHMP’s recommendation is based on the results of the phase III AURELIA study, which saw progression-free survival increase from 3.4 months to 6.7 months when Avastin was added to chemotherapy with paclitaxel or pegylated liposomal doxorubicin. Overall survival extended from 13.3 months to 16.6 months although the difference did not reach statistical significance.
Median survival in platinum-resistant ovarian cancer is typically around 12 months, and no single-agent therapy had shown superiority to paclitaxel, topotecan or liposomal doxorubicin prior to the trial results. Avastin also significantly improved abdominal/gastrointestinal symptoms by around 15 per cent in a pre-planned patient-reported outcome (PRO) sub-study.
“Women with platinum-resistant ovarian cancer have limited medicines available,” said Roche’s chief medical officer Sandra Horning. “EU approval of Avastin for platinum-resistant ovarian cancer would be an important step in helping these women live longer without their disease progressing.”
Ovarian cancer is already driving sales growth for Avastin at the moment, particularly in Europe, with the product helping Roche’s total first-quarter sales rise 9 per cent to 1.57bn Swiss francs ($1.75bn).
The drug is already approved in Europe as a first-line treatment for advanced ovarian cancer alongside paclitaxel and carboplatin, as well as for recurrent, platinum-sensitive ovarian cancer. To date it has not been approved in the US in any ovarian cancer indication.
Roche is also developing Avastin as a combination alongside its anti-PDL1 therapy MPDL3280A, which won breakthrough designation from the US FDA last month, in a number of indications including renal cell carcinoma.