Looks like this is going to be my last blog post of the year.
I'll save any words of wisdom for a couple of weeks from now, when I do my diagnosiversary post (though I'm not promising anything to wise). But I did think it might be nice to look back at the year.
I'm going to let an article from Medpage Today do some of the work for me. "Year in Review: Follicular Lymphoma" was published December 1, but it covers some of the good some of what happened this year for FL.
The subtitle for the article is "A Promising Year for Bispecific Antibodies," and that is indeed the focus of the article. Though the article says that the year began with the FDA approval for Mosunetuzumab, that actually happened in late December 2022. But since the article was published a month before the end of the year, we'll forgive them for getting their dates mixed up.
The important thing is, the bispecific was improved, and the numbers from the clinical trial were great -- an Overall Response Rate of 80%, with Complete Responses of 60%, and a median duration of almost 2 years. Those are very good numbers, and follow-ups and expanded studies of Mosunetuzumab just confirm this (I'll try to write about one of the follow-up studies soon).
In addition to the approval, bispecifics as a class got more good news from the FDA, with Glofitimab getting accelerated approval in July for Diffuse Large B-Cell Lymphoma, including patients whose FL had transformed (I didn't write about this in the blog), and Odronextamab getting priority review in October from the FDA based on its phase 2 trial. Great numbers here, too -- ORR of 82% and CRR of 75%, with the CRs lasting a median of 20.5 months.
And finally, the FDA gave breakthrough designation for Epcoritamab, yet another bispecific antibody.
The other bit of news that the article gives is the PI3K inhibitor Copanlisib being pulled from the market in November. I've written enough about that already -- no more comment.
In terms of FDA approvals, that about covers what happened for the year. But I think there were lots of other good things, too. Progress happens in small steps -- sometimes smaller than we'd like. But those small steps are worth celebrating, too.
So I would add a few more things to the year in review.
- Phase 2 trial results for Liso-cel were very positive. An eventual approval would give us a third option for CAR-T treatments.
- The FDA has accepted a supplemental Biologics License for the combination of Zanubrutinib (a BTK inhibitor) and Obinutuzumab (a monoclonal antibody) for patients with R/R Follicular Lymphoma. A decision should be made in the next couple of months.
- Subcutaneous Rituxan performed very well in a phase 3 trial. Approval could mean less time and lower costs for those receiving the treatment.
- Rituxan celebrated its 25th birthday.
These are all excellent things. Looking at the headlines from conferences like ASH and ASCO, it seems like DLBCL and Multiple Myeloma had excellent years compared to FL. Lots of bigger steps forward for them.
But I'm OK with our little steps forward. Good things are continuing to happen for FL patients, and many more good things are to come.
I hope you all have a very happy new year. I look forward to sharing more with you in 2024.
1 comment:
Thank you Bob for all the good work.
A happy 2024!
Ron, The Netherlands
Diagnosed july 2016(stage 3a) R–CVP plus 2 years R maintenance.
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