FDA Fully Approves Clolar
The U.S. Food and Drug Administration (FDA) has fully approved Clolar® (clofarabine). It is a nucleoside metabolic inhibitor that was given the FDA’s Accelerated Approval in December 2004 as third-line or later treatment for relapsed or refractory acute lymphoblastic leukemia (ALL) in pediatric patients at least one year old, but no older than 21 years old.
As a condition of the initial approval, which was based on promising interim results from clinical studies, Genzyme was required to conduct continuing trials to support the drug’s effectiveness. The FDA found that the conditions for full approval had been met, so the approval was upgraded on July 18, 2022.
Clolar is delivered at a dose of 52 mg/m2 as a two-hour-long intravenous (IV) infusion on each of the first five days of 28-day cycles. Depending on how quickly patients recover from Clolar’s significant side effects, cycles can be spaced as little as two weeks apart; usually with no more than six weeks between 28-day treatment periods. Heart, kidney and liver function should be watched for all patients during active infusions. One-quarter or more of patients develop potentially serious side effects that can include fast heartbeats, fatigue, fever, headaches, itching, low blood pressure, rash, and deficiencies of specific blood components.
Several generics are available for Clolar in the United States.
New Pediatric Indication for Benlysta
GSK (formerly GlaxoSmithKline) received FDA approval on July 26, 2022, for Benlysta (belimumab) as treatment for active lupus nephritis among patients who are between the ages of five years and 18 years old. It now has approvals for use in combination with standard treatment, which usually includes corticosteroids, cyclophosphamide, and immunosuppressants, for patients who are at least five years old and who have systemic lupus erythematosus (SLE) and/or lupus nephritis.
SLE is an autoimmune disease characterized by inflammation in connective tissues. It can affect the joints and numerous organs, including the heart, kidneys and skin. With an estimated incidence of 16,000 cases per year and a prevalence of about 1.5 million in the U.S., it strikes many more women than men. SLE is believed to affect between 5,000 and 10,000 American children. Approximately one-half of patients who have SLE are thought to have lupus-associated nephritis; and about 10% eventually develop end stage renal disease (ESRD).
A unique monoclonal antibody, Benlysta inhibits the protein, B-lymphocyte stimulator (BLyS), which is elevated in patients who have SLE. BLyS contributes to the production of cells that attack patients’ blood vessels and organ systems. Although it is available in both IV and subcutaneous (SC) forms, only Benlysta’s IV injection is approved for patients less than 18 years old. It must be given as a one-hour IV infusion at 10mg/kg in a facility that is staffed and equipped to manage any infusion reactions that could occur. Each of the first three doses are two weeks apart, and then dosing switches to once every four weeks.
Recall: Additional Magnesium Citrate Products
On July 25, 2022, Vi-Jon extended its previous recall of lemon-flavored magnesium citrate to include all lots of all flavors for over-the-counter magnesium citrate products that are made in the same facility and packaged in 10-ounce bottles. Vi-Jon makes products that are sold under many different brand names. The recalled bottles may contain bacteria that could cause severe infections for patients who have weakened immune systems.