Vincent Rajkumar: ODAC votes 11-0 to recommend approval of Cilta-Cel in patients with relapsed/refractory multiple myeloma in earlier stages

Vincent Rajkumar, Editor in Chief of Blood Cancer Journal, shared on X/Twitter:

“Breaking: ODAC votes 11-0 to recommend approval of Cilta-Cel in patients with relapsed/refractory multiple myeloma in earlier stages.

I’m glad. Right call. But we need to be careful. Read on.

There are a lot of good treatments for earlier stages of relapsed myeloma with long track record of efficacy and safety.

We need more data on sequencing of CART vs established treatments for relapsed disease in terms of overall survival, cost, and toxicity.

For late line treatment benefits of CART outweigh the risks of T cell lymphoma and neurotoxicity. But as we move to earlier lines caution is needed.

I’d consider CART outside of a trial in 2nd or 3rd relapse. But not for now in first relapse except in unusual circumstances.

There is also issues of access and cost. Myeloma treatments are characterized by high costs and disparities. As early relapse treatments just start become affordable it’s hard to justify extraordinarily expensive replacements without more data on safety and efficacy for sequencing.

On the other hand CART is exciting and offers patients the opportunity for prolonged treatment free intervals.

Earlier use of CART may also provided longer PFS and better outcomes.

So if FDA goes along with the ODAC vote, I’m glad that the decision on timing and sequence of CART will be in hands of clinicians.

At present CART is approved only for fifth line and that’s not good either for patients.

Also want to congratulate Janssen US for pulling off a hard randomized controlled trial.

Not an easy trial to plan and execute. Kudos.

Same considerations and comments for Idecel.”

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Source: Vincent Rajkumar/X