FDA’s rejection of Avastin creates conflict
pharmafile | October 31, 2011 | News story | Research and Development, Sales and Marketing | FDA, avastin, breast cancer
Oncology experts have expressed concern at the FDA’s rejection of Roche’s Avastin for the treatment of advanced breast cancer.
A new survey in the journal Cancer finds that the regulator’s decision to remove Avastin (bevacizumab)’s indication for metastatic breast cancer (MBC) has created discord in the medical community.
Avastin received accelerated approval from the FDA for MBC in 2008 on the basis that the drug combined with chemotherapy increased progression-free survival (PFS).
But the regulator rejected the drug after study results showed it did not significantly benefit patients, and that there were serious side effects.
However, of the more than 500 people who responded to the Cancer survey, nearly half (46.5%) indicated that they would use Avastin for triple receptor–negative MBC.
And another 44% would use it in a first line setting while 51% would use it in combination with paclitaxel for MBC.
The survey’s organisers say participants ”believed PFS to be a surrogate for overall survival, that cost played a role in the FDA’s decision, and that the decision would adversely affect the future of newer drugs currently being investigated for MBC”.
Nearly a third of respondents (31%) were from Europe, 22% from the US and Canada, 11.1% from Asia and exactly a third from other countries.
”The controversy surrounding the FDA’s decision on possibly withdrawing bevacizumab from its indication for use among women with MBC was felt across the globe,” lead author Shaheenah Dawood told Reuters Health.
Dawood’s study was set up to assess the perception of community oncologists on how the FDA’s decision will affect practice and to establish the typical use of the drug in MBC.
Despite the FDA setback, Avastin remains a significant force in the treatment of other cancers, and recently received European regulatory backing for a new indication in ovarian cancer.
The European Medicines Agency’s CHMP recently supported its use with carboplatin and paclitaxel for advanced epithelial ovarian, primary peritoneal or fallopian tube carcinoma.
Adam Hill
Related Content
GSK’s Jemperli accepted for FDA review for endometrial cancer treatment
GSK has announced that the US Food and Drug Administration (FDA) has accepted its supplemental …
FDA approves ImmunityBio’s Anktiva bladder cancer treatment
ImmunityBio has announced that the US Food and Drug Administration (FDA) has approved Anktiva (N-803, …
Roche’s Alecensa approved by FDA as lung cancer treatment
Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …
