FDA OKs Hormone-Free Pill for Hot Flashes
The FDA approved the first-in-class drug fezolinetant (Veozah) for the treatment of moderate to severe hot flashes caused by menopause, the agency announced Friday. The oral neurokinin 3 (NK3) receptor antagonist is a non-hormonal treatment that works to block the activities of the NK3 receptor, which plays a role in the brain’s regulation of body […]
The Biggest Warning Signs That You’re Experiencing Early Menopause
Yana Iskayeva via Getty Images Hormone therapy can be a necessary treatment for some people experiencing early or premature menopause. For half of the population, menopause is something that occurs during middle age and is a sign of the end of the reproductive years. “Menopause is a natural process that occurs in women when their […]
FLT3 Inhibitor Doubles Overall Survival in Acute Myeloid Leukemia
Incorporating quizartinib into standard treatment for newly diagnosed acute myeloid leukemia (AML) followed by maintenance therapy with the investigational FLT3 inhibitor improved survival for patients with internal-tandem-duplication (ITD) mutations of FLT3, a placebo-controlled randomized trial showed. In the phase III study of over 500 patients undergoing standard induction and consolidation therapy, median overall survival (OS) […]
FDA Staff Not Sold on Broad Olaparib Indication in Metastatic CRPC
Olaparib (Lynparza) plus abiraterone (Zytiga) as initial treatment for metastatic castration-resistant prostate cancer (CRPC) is only clearly effective in patients with BRCA mutations, FDA staff contended in a briefing document released ahead of an advisory committee meeting. On Friday, the FDA is asking its Oncologic Drugs Advisory Committee (ODAC) to weigh in on whether a […]
FDA Greenlights New First-Line Regimen in Bladder Cancer
The FDA gave accelerated approval to enfortumab vedotin (Padcev) and pembrolizumab (Keytruda) as first-line treatment for certain patients with locally advanced or metastatic urothelial cancer, the agency announced on Monday. Specifically, the combination is indicated for those who are ineligible for cisplatin-containing chemotherapy, and the approval marks the first anti-PD-1/antibody-drug conjugate combination for this patient […]
Post-Immunotherapy Combo Promising in Advanced RCC
Combination treatment with a hypoxia-inducible factor (HIF) 2α inhibitor and tyrosine kinase inhibitor induced responses in nearly a third of advanced renal cell carcinoma (RCC) patients previously treated with immunotherapy, a single-arm phase II study found. In the study of 52 patients, 30.8% (95% CI 18.7-45.1) had a confirmed objective response following treatment with belzutifan […]
OTC Narcan Approval Opens New Doors in Fight Against Opioid Crisis
This week’s FDA approval of the first-ever over-the-counter (OTC) naloxone product (Narcan) for the treatment of opioid overdoses was broadly praised, but medical and industry experts expressed caution about expanding access and its potential to address the overdose crisis. “We have nearly 200 Americans dying every day as a result of opioid-involved overdose,” said Smita […]
Evaluating and Treating Children With Long COVID
Experts shared advice on diagnosis and treatment of children and adolescents showing signs of post-COVID conditions — also known as long COVID — during a CDC Clinician Outreach and Communication Activity (COCA) webinar. “Post-COVID conditions” is the preferred term of the CDC and is defined as “the wide range of physical and mental health consequences […]
Combo Falters in Papillary Renal Cancer, but Some Promise in MET-Driven Subset
Treatment with an investigational MET inhibitor plus a PD-L1 inhibitor induced responses in fewer than a third of patients with metastatic papillary renal cancer, but the combination showed promise for one subgroup, findings from the phase II CALYPSO trial showed. In the single-arm study, 12 of 41 patients (29%, 95% CI 16-46) had a confirmed […]
FDA Approves First Treatment for Geographic Atrophy Secondary to AMD
The FDA approved pegcetacoplan injection (Syfovre) as the first treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD), according to a statement from Apellis Pharmaceuticals. Primary support for the approval came from the randomized, sham-controlled DERBY and OAKS trials, which showed a 22% overall reduction in growth of GA with pegcetacoplan over 24 […]