FDA to Cancel License Indication of Bevacizumab

Genentech has a new proposal for keeping its licensed indication for bevacizumab (Avastin) in breast cancer.

Genentech has come up with a proposal to maintain license of its medicine Bevancizumab. Genentech wants FDA to maintain breast cancer as licensed indication of Bevancizumab. The drug is brand named as Avastin and is used in treatment of cancer (Metastatic Colorectal Cancer).

US FDA is mulling to cancel the license of the drug for usage in breast cancer treatment. Commissioner of FDA is yet to confirm it.

Despite manufacturer's efforts to convince review team not to revoke the license, members of drug review panel has voted against use of the drug in breast cancer.

In meeting, company addressed many concerns which were expressed by members of panel. Genentech argued that patients suffering from metastatic disease had fewer approved treatments. Manufacturer claimed, in documentation submitted to FDA, Bevacizumab has been found very effective when administered with paclitaxel in patients who are suffering from severe form of metastatic.

With these facts company advocated fast approval of bevacizumab plus paclitaxel subject to supporting research and change in labeled usage if risk factors are addressed.

Genentech sought revised labeling and change in indication of the drug Bevacizumab. According to new proposal, the drug remains in metastatic breast cancer but its usage would be limited in women with severe type of breast cancer such as severe hormone receptor positive breast cancer or triple negative cancer.

Senators Seek Change in FDA's Interest Conflict Rule

A vital amendment is on way. US senators are about to bring change in rule for advisers involve in reviewing new drug approvals. This is because there were lots of cases when FDA could not find experts because of conflicts of interest.

Lawmakers want FDA to loose regulations according to which advisers are not allowed to review new drug application if the respective person is financially associated with manufacturers. Current regulation makes it hard to find experts to be hired on review panel.

FDA is largely funded by fees taken from manufacturer of drug who are seeking FDA approval to make drug available in market. Hence, FDA's funding bill is a way to make major changes in the way FDA work.

Issue was raised by Mike Enzi and Al Franken, senators from Republican and Democratic party respectively.

FDA has to postpone meeting of drug-review committee while finding adviser without any conflicts. Expert doctors are already recruited by manufacturers as consultant and rule prevents FDA to hire same doctor in advisory panel.

FDA in May reported 23% vacant position in advisory panel.

Although FDA is free to avoid recommendations from advisor, it usually follows.

In the wake of Vioxx pain drug controversy, FDA made regulatory changes which restricted appointment of a person with financial ties fearing impact on one's view.

There are currently 10 panelists in FDA advisory panel who were also consulted by drug manufacturers. 9 panelists recommended bringing a drug in market which was called back in 2004.

Hamburg, FDA Commissioner, is also in favour of relaxed rule.