Pembrolizumab, Secukinumab, Ustekinumab biosimilar, Vonoprazan, Abatacept, Exa-cel

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:

• Pembrolizumab (Keytruda) has received FDA approval for the treatment of metastatic biliary tract cancer, both in combination with chemotherapy and as a monotherapy. The approval is based on the positive outcomes of the KEYNOTE-966 trial, where patients receiving pembrolizumab plus chemotherapy demonstrated a statistically significant improvement in overall survival compared to those receiving a placebo with chemotherapy. Common adverse reactions included hematologic abnormalities, pyrexia, fatigue, cholangitis, and hepatic enzyme elevations. Approval was granted to Merck.
• Secukinumab (Cosentyx) has gained FDA approval for the treatment of moderate-to-severe hidradenitis suppurativa (HS), making it the first FDA-approved IL-17A inhibitor for this condition. Approval is based on results from the SUNSHINE and SUNRISE trials, showing significant improvements in response rates in HS patients treated with secukinumab compared to placebo.
• Ustekinumab-auub (Wezlana) has been granted FDA approval as an interchangeable biosimilar for Stelara, offering treatment options for multiple inflammatory diseases. It is indicated for moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in adult patients, as well as pediatric patients with plaque psoriasis and psoriatic arthritis.
• Vonoprazan (Voquezna) has received FDA approval for the treatment of erosive esophagitis (GERD). As a potent potassium-competitive acid blocker (PCAB), it offers an alternative to proton pump inhibitors (PPIs). Approval is based on the PHALCON-EE study, where vonoprazan demonstrated noninferiority to lansoprazole in healing GERD.
• Abatacept (Orencia) has been expanded for use in pediatric patients aged 2 years and older to treat psoriatic arthritis. Originally approved for rheumatoid arthritis in adults in 2005, abatacept was also approved for adult psoriatic arthritis in 2017.
• Exa-cel, a CRISPR-based therapy developed by CRISPR Therapeutics and Vertex, is under FDA review for sickle cell disease. The advisory panel has found it safe for clinical use, with potential approval expected in December. Exa-cel aims to alleviate sickle cell symptoms through gene editing technology

Intro and outro music

Garden Of Love by Pk jazz Collective