FDA Approval Insights: Imetelstat in Lower-Risk MDS and Transfusion-Dependent Anemia

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, sponsored by Geron, we had the pleasure of speaking with Mikkael A. Sekeres, MD, about the FDA approval of imetelstat (Rytelo) for patients with lower-risk myelodysplastic syndrome (MDS) and transfusion-dependent anemia. Dr Sekeres is a professor of medicine and chief of the Division of Hematology in the Leukemia Section at the University of Miami Sylvester Comprehensive Cancer Center in Florida.

On June 6, 2024, the FDA approved imetelstat for the treatment of adult patients with low-to-intermediate-1–risk MDS and transfusion-dependent anemia requiring at least 4 red blood cell (RBC) units over 8 weeks who have lost response to, have not responded to, or are not eligible for erythropoiesis stimulating agents. This regulatory decision was based on data from the phase 3 IMerge trial (NCT02598661), in which patients treated with imetelstat (n = 118) had an 8-week RBC transfusion independence (RBC-TI) rate of 39.8% (95% CI, 30.9%-49.3%) compared with 15% (95% CI, 7.1%-26.6%) in those who received placebo (n = 59; P < .001).

In our exclusive interview, Dr Sekeres discussed the significance of this approval, key findings from IMerge, and how the use of imetelstat affects RBC-TI rates in the absence of platelet transfusions or myeloid growth factors in this patient population.

___

That’s all we have for today! Thank you for listening to this episode of OncLive On Air, sponsored by Geron. Check back on Mondays and Thursdays for exclusive interviews with leading experts in the oncology field.

For more updates in oncology, be sure to visit www.OncLive.com and sign up for our e-newsletters.

OncLive is also on social media. On Twitter, follow us at @OncLive. On Facebook, like us at OncLive, and follow our OncLive page on LinkedIn.

If you liked today’s episode of OncLive On Air, please consider subscribing to our podcast on Apple Podcasts, Spotify, Google Podcasts, Amazon Music, and many of your other favorite podcast platforms,* so you get a notification every time a new episode is posted. While you are there, please take a moment to rate us!

Thanks again for listening to OncLive On Air.

*OncLive On Air is available on: Apple Podcasts, Google Podcasts, Spotify, Amazon Music, Audacy, CastBox, Deezer, iHeart, JioSaavn, Listen Notes, Player FM, Podcast Addict, Podchaser, RadioPublic, and TuneIn.