FDA Grants Accelerated Approval to Zenbexus Combination for Relapsed Multiple Myeloma | iPharmaCenter
The US Food and Drug Administration has granted accelerated approval to Zenbexus, also known as iberdomide, in combination with daratumumab and hyaluronidase plus dexamethasone for adults with multiple myeloma previously treated with at least one regimen containing both a proteasome inhibitor and an immunomodulatory medicine. The approval is based on findings from the Phase 3 EXCALIBER-RRMM study, which evaluated the Zenbexus combination in patients with relapsed or refractor
8 hours ago2 min read
FDA clears Pluvicto earlier in PSMA positive metastatic prostate cancer
The U.S. Food and Drug Administration has authorized Pluvicto for use with standard hormone blocking regimens in adults with PSMA positive metastatic hormone sensitive prostate cancer. The decision allows clinicians to combine the radioligand therapy with androgen deprivation and androgen receptor pathway inhibitors in patients whose disease is still hormone sensitive, significantly increasing the group eligible for this targeted approach. PSMAddition data underpin the label
Aug 42 min read
FDA Approves Otsuka’s SIMTRIYO as First-in-Class NDSRI for ADHD
The U.S. Food and Drug Administration has granted approval to Otsuka Pharmaceutical for SIMTRIYO (centanafadine), marking the first regulatory clearance for a norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) intended for the treatment of attention-deficit/hyperactivity disorder (ADHD). Indicated for pediatric patients aged 6 years and older weighing at least 20kg, as well as adult patients, the medication is formulated as a once-daily, extended-release capsule.
Jul 272 min read
FDA Approves First Oral PCSK9 Inhibitor, Signaling Shift in Dyslipidemia Treatment
Merck has secured FDA approval for LIPFENDRA (enlicitide) 20 mg tablets, establishing the first oral PCSK9 inhibitor available for the management of hypercholesterolemia. Approved as an adjunct to diet and exercise, the macrocyclic peptide is indicated for adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). Also read: CMS Proposes Major Medicare Overhaul: Shifting Toward Accountable Care and Value-Based Payments The therap
Jul 172 min read
FDA Grants Landmark Approval for REVTORPYK: A New Standard for PIK3CA Wild-Type Breast Cancer
The U.S. Food and Drug Administration (FDA) has approved Celcuity’s REVTORPYK (gedatolisib) for the treatment of HR+/HER2- metastatic breast cancer patients who do not possess a PIK3CA mutation. As the first therapy capable of inhibiting all class I PI3K isoforms (α, β, δ, γ) in conjunction with both mTORC1 and mTORC2 complexes, REVTORPYK introduces a novel mechanism of action for a patient population that accounts for approximately 42% of all HR+/HER2- diagnoses. Also read:
Jul 152 min read