Thread by @VincentRK

Although we have multiple options to treat myeloma, the number of highly effective drug classes are few and just not enough.

We continue to have an unmet need for relapsed myeloma. We continue to need accelerated approval by the FDA. @Rfonsi1 @NorthTxMSG #IMS2022 #IMS2022VR
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We also need accelerated approval of multiple drugs of the same class because patients tolerate one better than the other, and sometimes one works better than the other. It is also important to have competition to foster more innovation and to have some effect on price.

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The fact we have made so much progress in myeloma does not mean we don’t need more drugs.

Myeloma remains a serious malignancy and we continue to have unmet needs. So I will continue to advocate for rapid approval of new drugs.
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In myeloma we have excellent biomarkers to identify effective treatments.

The benefits of rapid approval in myeloma far outweigh the risks.
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The accelerated approval of myeloma drugs from bortezomib to daratumumab, from carfilzomib to CAR-T has saved countless lives in the US.

We can save a lot more lives once bispecifics and other new drugs become available.
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Every cancer is different. Every drug is different. The magnitude of benefit thats expected or possible varies by drug, and by malignancy.

So this thread is specific for myeloma where I’m confident of the disease and the drugs to make a judgment call on the pros and cons.
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I am not able to generalize this approach for other cancers and I’m not advocating blanket endorsement of accelerated approval strategies. That’s something experts in each field will have to make based on the disease and the drug.
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It is of paramount importance that accelerated approval go hand in hand with rapid completion of phase III trials to demonstrate clinical benefit.
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Importantly clinicians should recognize that phase III trials designed to demonstrate clinical benefit and fulfill the regulatory requirements may or may not provide insight into how the drug is best used in the overall myeloma treatment strategy.
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The myeloma field has been good about conducting and completing phase III trials for drugs going through accelerated approval. And good about discarding drugs that are not proven effective.
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