HER2 Support Group Forums - View Single Post - !!! Pertuzumab may be approved by FDA as early as Friday !!!!

Lani · 06-07-2012, 04:08 PM

pertuzumab will probably not be useful as monotherapy(and thus is not a substitute for herceptin), but wil combined with herceptin (where it will be especially effective against the her2-her3 heterodimers) and even also lapatinib. It may/will probably end up being somewhat more effective when used with a taxane (although I hope not, as it would be lovely to have a purely targeted therapy only combination). Kent Osbourne and Racheal Schiff have opined that it might require an AI in the combo in ER+ her2+ cases.

Approval for a drug in the metastatic setting usually comes long before approval in the adjuvant setting as 80-90++% of those who are stage IV have historically succumbed within 10 years, whereas most of those in the earlier stages 90% or more never have a recurrence. When so many are expected to do just fine, they must weigh the safety issues in the cost/risk/benefit analysis. As an example I believe herceptin was approved for metastatic her2+ bc in the late 1990s but not for early breast cancer until late 2006 or sol

The good news was pertuzumab did not seem to be responsible for any more cardiotoxicity when added to herceptin compared to herceptin alone.

06-07-2012, 04:08 PM	#33
Lani Senior Member Join Date: Mar 2006 Posts: 4,778	Re: !!! Pertuzumab may be approved by FDA as early as Friday !!!! pertuzumab will probably not be useful as monotherapy(and thus is not a substitute for herceptin), but wil combined with herceptin (where it will be especially effective against the her2-her3 heterodimers) and even also lapatinib. It may/will probably end up being somewhat more effective when used with a taxane (although I hope not, as it would be lovely to have a purely targeted therapy only combination). Kent Osbourne and Racheal Schiff have opined that it might require an AI in the combo in ER+ her2+ cases. Approval for a drug in the metastatic setting usually comes long before approval in the adjuvant setting as 80-90++% of those who are stage IV have historically succumbed within 10 years, whereas most of those in the earlier stages 90% or more never have a recurrence. When so many are expected to do just fine, they must weigh the safety issues in the cost/risk/benefit analysis. As an example I believe herceptin was approved for metastatic her2+ bc in the late 1990s but not for early breast cancer until late 2006 or sol The good news was pertuzumab did not seem to be responsible for any more cardiotoxicity when added to herceptin compared to herceptin alone.