Nirogacestat For Desmoid Tumors, Pirtobrutinib for CLL/SLL, Enfortumab Vedotin With Pembrolizumab for UC, Lisocabtagene Maraleucel for CLL/SLL, Xanomeline-trospium for Schizophrenia, Roflumilast for AD

New FDA Approvals

Summary:

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• Implementing AMA Style – 8 Things to Get Right in Your Next Project
• Needs Assessments – 7 Essentials for Getting Funded
• Working With Your Medical Writer – 8 Ways to Get the Most out of Them

See the full write ups for today's episode at nascentmc.com/podcast

Here are the highlights:

1. Nirogacestat (Ogsiveo) For Desmoid Tumors: Nirogacestat is the first FDA-approved drug for treating progressing desmoid tumors in adults, offering a significant improvement in response rate compared to placebo in a major trial.
2. Pirtobrutinib (Jaypirca) in CLL/SLL: The FDA granted accelerated approval for pirtobrutinib to treat adult patients with CLL/SLL who have undergone at least two prior therapies, with its effectiveness based on response rates from the BRUIN trial.
3. Enfortumab Vedotin (Padcev) With Pembrolizumab (Keytruda) for Urothelial Cancer: The FDA is reviewing a combination treatment of enfortumab vedotin and pembrolizumab for urothelial cancer under priority review, showing significant improvement in survival rates compared to chemotherapy in a Phase 3 study.
4. Lisocabtagene Maraleucel (Breyanzi) for CLL/SLL: The FDA is reviewing lisocabtagene maraleucel for expanded use in treating CLL/SLL patients who have relapsed after BTKi and BCL2i treatments, based on positive results from the TRANSCEND CLL 004 study.
5. Xanomeline-trospium (KarXT) for Schizophrenia: The FDA is considering xanomeline-trospium for treating schizophrenia, with potential benefits over traditional treatments in reducing common antipsychotic side effects, based on the EMERGENT program results.
6. Roflumilast Cream for Atopic Dermatitis: The FDA is reviewing roflumilast cream for treating atopic dermatitis in adults and children, supported by positive results from the INTEGUMENT-1 and INTEGUMENT-2 studies, with a potential for simplification in disease control.

See the full write ups for today's episode at nascentmc.com/podcast

Intro and outro music

Garden Of Love by Pk jazz Collective