Drugs.com - Monthly Update September 2025
Welcome to the September 2025 edition of Drugs.com Monthly Update, where we bring you the latest developments in pharmaceutical advances that impact both patients and healthcare providers. This episode uses AI tools to help with formatting, organization, and narration. All content has been reviewed by a senior editorial pharmacist.
Narrator:Today, we'll explore FDA approved therapies that are opening new treatment avenues for conditions like chronic spontaneous urticaria, acromegaly, and ESR1 mutated breast cancer. We'll also look into a novel therapy for the ultra rare Barth syndrome and a new subcutaneous formulation of Keytruda. Let's dive right into these significant updates.
Narrator:First up, let's talk about Rhapsido, spelled R H A P S I D O, the newest approval for adults facing chronic spontaneous urticaria, or CSU. This bothersome skin condition, characterized by unpredictable, itchy hives without an obvious cause, often leaves patients seeking alternatives when standard antihistamines fail.
Narrator:Rhapsido represents a breakthrough as the first Bruton's Tyrosine Kinase inhibitor for CSU. By blocking critical pathways in mast cells and basophils, Rhapsido helps prevent the release of pro inflammatory mediators.
Narrator:The FDA's nod came after promising results from Phase 3 trials demonstrated its superior itch and hive control over placebo. However, patients should be aware of a heightened bleeding risk among other side effects like headache and nausea.
Narrator:Next is Palsonify, spelled P A L S O N I F Y, a significant approval for patients with acromegaly, which is often due to excessive growth hormone secretion from pituitary adenomas. This leads to a spectrum of symptoms, from joint aches and fatigue to more serious organ enlargement. Palsonify is notable as the first once daily oral option improving on the usual long cycle injectable therapies.
Narrator:It acts by targeting somatostatin receptors to control growth hormone levels. Clinical trials showed fast biochemical control and a sustained efficacy, offering a promising oral treatment alternative. When considering Palsonify, patients and providers should note precautionary measures due to potential complications like cholelithiasis and thyroid abnormalities.
Narrator:Turning to oncology, we have Inluriyo, spelled I N L U R I Y O, for patients battling ESR1 mutated breast cancer with progression despite previous endocrine therapy. This once daily oral drug serves as a selective estrogen receptor degrader, crucial in neutralizing overactive receptors propelling cancer growth.
Narrator:The EMBER-3 trial's results showed a 38% risk reduction in progression or death compared to endocrine therapy. Safety considerations include embryo fetal toxicity with common side effects ranging from nausea to musculoskeletal discomfort.
Narrator:Shifting focus to rare diseases, there's an exciting advancement for Barth syndrome with Forzinity, spelled F O R Z I N I T Y, designed to aid muscle strength in patients weighing at least 30 kg. Barth syndrome's debilitating symptoms include muscle weakness and cardiac problems. By enhancing mitochondrial function, Forzinity offers a new hope for improved daily functioning.
Narrator:Administrable via daily subcutaneous injection, the main side effects noted were injection site reactions.
Narrator:Lastly, we have an easier, more convenient formulation of Keytruda, spelled K E Y T R U D A, with Keytruda Qlex. Previously reliant on longer intravenous infusions, this subcutaneous version delivers pembrolizumab more rapidly, benefiting patients with solid tumors such as melanoma. The formulation combines pembrolizumab with berahyaluronidase alfa to facilitate subcutaneous delivery, maintaining effectiveness without impacting progression free survival.
Narrator:Thank you for tuning in to the Drugs.com monthly update podcast, where staying informed means staying ahead in your field.
Narrator:We look forward to bringing you more updates next month. Until next time, know more, be sure.
