Your source for the latest industry trends and drug information news.
Volume 7 | Issue 15
August 1, 2025
Contributors:
Chief Authors: Rebecca Waite, PharmD & Christina Ramsay, PharmD
Contributing Authors: Xintian Wu, PharmD/MBA Candidate, and Jessica Lin PharmD/MBA Candidate
On July 2, 2025, the Food and Drug Administration (FDA) approved Lynozyfic™ (linvoseltamab-gcpt) for the treatment of adult patients with relapsed (the cancer has returned after a period of time when the symptoms of the disease had temporarily lessened or disappeared) or refractory (the cancer either has stopped responding to treatment or has not responded to treatment) multiple myeloma. Multiple myeloma is a type of blood cancer involving a specific kind of white blood cells, called plasma cells, in the bone marrow. There is currently no cure for multiple myeloma, and the goal of treatment is to slow down the progression of disease. Lynozyfic™ is not a first-line therapy and is indicated in patients who have already received at least four other prior lines of therapy to treat their cancer. The FDA granted Lynozyfic™ an accelerated approval, which allows new drugs that fill an unmet need and/or treat a serious medical condition, like cancer, to be approved more quickly based on initial evidence showing clinical benefit. In an ongoing open-label, multicenter Phase 1/2 clinical trial, called LINKER-MM1, Lynozyfic™ achieved a 70% objective response rate (ORR) with the treatment, with 45% of participants achieving a complete response (CR). In addition, Lynozyfic™ demonstrated duration of response between 9 to 12 months at the time of analysis. The FDA requires confirmatory clinical trials for drugs that receive accelerated approval to confirm initial findings and validate efficacy.
Lynozyfic™ works by directing immune cells, called T cells, to kill multiple myeloma cancer cells. A healthcare provider must administer Lynozyfic™ intravenously (IV), and hospitalization is required for 24 hours after the first and second step-up doses to monitor patient for any severe adverse reactions to the medication. Lynozyfic™ has a “boxed warning”, also called a “black box warning”, in the package labeling to indicate potentially significant adverse side effects, a requirement by the FDA based on findings in clinical studies to communicate serious risks associated with a medication to healthcare providers and patients. Lynozyfic™ is only available through a restricted program, called a Risk Evaluation and Mitigation Strategy (REMS) program. REMS programs are required by the FDA for certain drugs with significant safety warnings to help ensure that benefits of therapy outweigh risks through communication, education, and/or patient monitoring.
On July 1, 2025, the FDA issued a drug safety communication pertaining to the use of extended-release stimulant medications, such as amphetamine-dextroamphetamine extended-release capsules and methylphenidate extended-release tablets, in patients younger than 6 years old. The drug safety communication from the FDA includes a warning regarding higher potential for weight loss when using these products in children under age 6, as weight loss can pose a serious concern in this population. The FDA is requiring drug manufacturers to update the package labeling of all extended-release stimulant products to include a warning for the risk of weight loss in pediatric patients under age 6.
Stimulant medications are available by prescription only and come in immediate-release (drug is released more quickly into the body) and extended-release (drug is released slowly over an extended time) dosage forms. Stimulant medications are used primarily for the treatment of attention deficit hyperactivity disorder (ADHD), a chronic neurodevelopmental condition that can affect brain function and behavior. ADHD is common in children and can affect a child’s attention span and the ability to follow directions and complete tasks. While some immediate-release stimulant medications are FDA-approved for use in patients 3 years and older, extended-release stimulant medications are only FDA approved for use in patients 6 and older. However, healthcare providers may prescribe extended-release dosage forms “off-label” (meaning the medication is being used outside of FDA approval) in children under age 6 if the benefits of therapy outweigh the risks. The updated labeling is intended to ensure prescribers are well informed of the risks associated with these medications.
On June 27, 2025, the Centers for Medicare & Medicaid Services (CMS) announced the launch of a new CMS Innovation Center model for Medicare, called the Wasteful and Inappropriate Service Reduction (WISeR) Model. Medicare is a federal insurance program that provides healthcare coverage primarily for patients aged 65 and older. Original Medicare, also called traditional Medicare, refers to Medicare Part A (hospital insurance), which covers hospital and inpatient stays and Medicare Part B (medical insurance), which covers outpatient services, like doctor visits and some preventative health screenings and vaccines. There is also Medicare Part D (prescription drug coverage), which helps cover the costs of prescription medications. An alternative option to traditional Medicare is also available to eligible patients who can enroll in plans called Medicare Advantage Plans (also known as Medicare Part C). Medicare Advantage Plans are Medicare-approved plans offered by a private health insurance company that typically cover Medicare Parts A, B, and D.
The CMS Innovation Center was established in 2010 as part of the Affordable Care Act (ACA). The goal of the CMS Innovation Center is to develop new healthcare service and payment models (also called alternative payment models, or APMs) that can be implemented to help improve patient health care while also lowering healthcare costs. These models are designed with a goal of improving efficiency, minimizing waste and maintaining a high level of value-based care to promote positive health outcomes and maximize clinical benefits among those receiving care. The WISeR model will be tested in select states, including New Jersey, Ohio, Oklahoma, Texas, Arizona and Washington, starting on January 1, 2026. As part of the model, prior authorization will be needed for 17 selected services identified by CMS as vulnerable to fraud, waste, abuse or inappropriate use. Prior authorization means that providers must get approval from Medicare prior to administering the requested service to the patient.
New Drug: Ekterly® (sebetralstat)
Oral tablets approved for the treatment of hereditary angioedema attacks in adult and pediatric patients 12 years and older. Hereditary angioedema is a rare genetic disorder in which a patient experiences episodes of severe swelling in areas of the body, including the arms, legs, face, lungs and intestines. [7/3/2025 – KalVista Pharmaceuticals, Inc.]
Eprontia® (topiramate)
Indication: For treatment of epilepsy, a seizure disorder, in patients 2 years and older and for preventative treatment of migraine in patients 12 years and older.
Dosage Form/Strength: 25mg/ml oral solution
Average Wholesale Price (AWP): Generic = $360/120ML bottle | Brand = $400/120ML bottle
