Yelak Biru

So the belantamab ODAC is on. Personally I hope the belantamab is approved for relapsed myeloma. It has many advantages and there is a unique need for the drug in relapsed refractory myeloma. If available we will have an important option to tackle very difficult situations for which other options are not possible or far more riskier. See thread. Yes there is a problem with belantamab dosing. But there is no question the drug works and with appropriate modification of dose frequency we won’t have the type of eye toxicity that’s been seen in the phase III trials. Note that we did not have the best dose for many myeloma drugs when they were first approved. Many are just not used in the dose that they were approved at: bortezomib, pomalidomide, carfilzomib, even bispecifics. But there is no question lives were saved due to early approval of these drugs even though the dosing was not ideal in regulatory trials of these drugs. It’s a balance between the risk of approving an effective life saving drug tested with a less than ideal dose in the regulatory phase III versus the risk of delaying approval and access by a very long time to find the best dose. In the case of belantamab, that would be years. In clinical practice we are able to modify dosing to the extent that’s not possible in a clinical trial. We also have learnt a lot since the regulatory trials already that help with optimizing dosing. So I hope for the best because in my opinion myeloma patients with relapsed refractory disease need belantamab available as an option.

Excellent - linvo approved for 🇺🇸 pts with myeloma! 👍🏻 Q2W & Q4W built into approval 👎🏻 FDA forced 4 prior lines again From press release: "0.95 month median time to first response." When I was a kid, time to 1st response with #MMsm BCMA bsAbs was always exactly 1.2 mo 😉