FDA expands scope of ovarian cancer drug
The US Food and Drug Administration has approved Roche-group Genentech’s application to market Avastin for patients with a specific type of ovarian cancer.
The drug has been cleared for use, either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, to treat patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
The approval was the result of data from two large Phase III studies, showing a five-month overall survival difference for women with platinum-sensitive recurrent ovarian cancer on Avastin plus chemotherapy compared to chemotherapy alone.
Findings of GOG-0213 demonstrated median overall survival 42.6 months for patients taking the Avastin regimen compared 37.3 months for those in the placebo arm, and also median progression-free survival (PFS) of 13.8 months vs 10.4 months, respectively.
The OCEANS study showed that Avastin in combination with chemotherapy significantly improved PFS compared to placebo plus chemotherapy (12.4 months vs. 8.4 months, respectively), but there was no significant improvement in overall survival with the addition of Avastin to chemotherapy.
In November 2014, the drug was given a US nod for the treatment of women with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan chemotherapy.
This latest decision means that Avastin is now cleared in the country for nine distinct uses across six different types of cancer.