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04-07-2018 | FDA | Drug approval | News

approvalsWatch

FDA expands indications for venetoclax, bevacizumab

medwireNews: Following a US FDA decision, venetoclax can now be used for a broader group of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), while bevacizumab can be prescribed for ovarian cancer patients in the adjuvant setting.

The initial approval for venetoclax in 2016 restricted the use of the drug to CLL patients who had received at least one prior therapy and harbored a 17p deletion. Now the FDA has extended the indication to include all previously treated CLL and SLL patients irrespective of 17p deletion status.

This decision is based on the phase III MURANO trial which showed significantly better progression-free survival (PFS) in patients with relapsed or refractory CLL who received venetoclax alongside rituximab than those given bendamustine plus rituximab.

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Bevacizumab, initially given alongside chemotherapy and then as a single agent, is now approved for women who have undergone resection of stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer.

This follows on from the GOG-0218 trial in which median PFS was 18.2 months for the group that received bevacizumab plus carboplatin and paclitaxel for six cycles, followed by single-agent bevacizumab for up to 16 doses. This was higher than the median PFS of 12.8 months for the women given bevacizumab and chemotherapy, without additional bevacizumab monotherapy, and 12.0 months for those who received just chemotherapy.

The recommended dose of bevacizumab in this setting is 15 mg/kg every 3 weeks for a total of up to 22 cycles.

By Shreeya Nanda

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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