FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma.

Author: CollazoJustin S, DahmaneElyes, EarpJustin, GormleyNicole J, GrimsteinManuela, KasamonYvette L, LeongRuby, LiPing, RodriguezLisa R, TelarajaDeepti, TheoretMarc R, WangKun, YangYuching

Overview

Pिर्टोब्रुटिनिब एक नयाँ दवा हो जुन ब्रुटन टायरोसिन किनेज (BTK) अवरोधक हो जुन रिल्याप्स वा रिफ्रेक्टरी म्यान्टल सेल लिम्फोमा (MCL) को उपचारको लागि अमेरिकी खाद्य र औषधि प्रशासन (FDA) द्वारा तीव्र अनुमोदन प्राप्त गर्‍यो। यसको प्रभावकारिता रिलेप्स वा रिफ्रेक्टरी एमसीएल भएका 120 बिरामीहरूमा एकल-हात ब्रुइन अध्ययनमा आधारित थियो जसले पहिले BTK अवरोधक प्राप्त गरेका थिए। यस अध्ययनमा, 200 मिलीग्रामको एक पटक दैनिक खुराकमा पिर्टोब्रुटिनिबले 50% समग्र प्रतिक्रिया दर (ORR) देखाएको थियो, जुन 8.3 महिनाको औसत प्रतिक्रिया अवधि संग। सबैभन्दा सामान्य प्रतिकूल प्रतिक्रियाहरू थकान, मस्कुलोस्केलेटल पीडा, दस्त, इडिमा, डिस्पनिया, निमोनिया र चोट थिए।
Paper Details 
Original Abstract of the Article :
In January 2023, the U.S. Food and Drug Administration granted accelerated approval to pirtobrutinib for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. Approval w...See full text at original site
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引用元:
https://doi.org/10.1158/1078-0432.CCR-23-1272

データ提供:米国国立医学図書館(NLM)

Pirtobrutinib: A New Weapon in the Fight Against Mantle Cell Lymphoma

This research delves into the world of oncology, focusing on the use of pirtobrutinib for treating relapsed or refractory mantle cell lymphoma (MCL). The U.S. Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib for this indication, based on promising results from the BRUIN study. The study demonstrated significant efficacy in patients who had previously received other therapies, including a Bruton tyrosine kinase (BTK) inhibitor. While pirtobrutinib showed promising results in terms of response rate and duration, the study also highlighted the need for further investigation into its long-term safety.

Pirtobrutinib's Promise: A New Hope for Mantle Cell Lymphoma Patients

This research provides a glimmer of hope for individuals battling relapsed or refractory mantle cell lymphoma. The study's findings suggest that pirtobrutinib holds the potential to improve outcomes for patients who have exhausted other treatment options. However, it's important to note that this is an early-stage study, and further research is needed to confirm pirtobrutinib's long-term efficacy and safety.

Navigating the Path to Better Lymphoma Treatments

This research is a testament to the ongoing efforts to develop innovative therapies for various types of cancer. While pirtobrutinib shows promise, it's crucial to remember that each individual's response to treatment can vary. This research highlights the importance of personalized medicine and the need for ongoing research to find better and safer therapies for patients battling lymphoma and other cancers.

Dr. Camel's Conclusion

This research takes us on a journey through the challenging landscape of lymphoma treatment, showcasing the development of a new agent, pirtobrutinib. While pirtobrutinib holds promise as a potential treatment option, further research is essential to fully understand its long-term impact. Like a camel navigating a desert oasis, we must proceed with caution and thorough investigation to ensure the best possible outcomes for patients battling lymphoma.

Date :
  1. Date Completed n.d.
  2. Date Revised 2023-08-25
Further Info :

Pubmed ID

37624619

DOI: Digital Object Identifier

10.1158/1078-0432.CCR-23-1272

Related Literature

SNS
PICO Info
in preparation
Languages

English

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