New Breyanzi Indication
On May 15, 2024, the FDA awarded Bristol Myers Squibb’s Breyanzi® (lisocabtagene maraleucel) an additional Accelerated Approval for treating adults who have follicular lymphoma (FL) that have recurred or have become resistant to two or more other treatments. Also called liso-cel, Breyanzi is an autologous chimeric antigen receptor (CAR-T) modified T-cell therapy that targets the CD19 antigen expressed by many B-cell malignancies. Doses are tailored to each patient using their own genetically modified T-cells, which have been engineered to attack cancer cells once infused back into the patient. It is administered as one intravenous (IV) infusion. Initially, FDA approved in February 2021, it treats adults who have relapsed or refractory diffuse large B-cell lymphomas (r/r DLBCL) that have not responded to at least one other type of systemic treatment. It also has Accelerated Approval as third- or later-line therapy for adults who have r/r chronic lymphocytic leukemia (r/r CLL) or small lymphocytic lymphoma (r/r SLL). In the phase II TRANSCEND FL study that led to the most recent approval, 95.7% of the patients who received Breyanzi responded at least partially to treatment and 77.1% of responders have had a clinical benefit for at least 18 months. Further documentation of its effectiveness and safety for treating r/r FL, r/r CLL, and r/r SLL will be needed for full FDA approvals. Labeling for Breyanzi carries a boxed warning and it has a patient Medication Guide due to potentially life-threatening cytokine release syndrome (CRS), neurological events, and T-cell cancers that may be related to its use. It is available only through hospitals and associated outpatient clinics that are certified through a Risk Evaluation and Mitigation Strategy (REMS) program. Two other CAR-T drugs, Kymriah® (tisagenlecleucel – Novartis) and Yescarta® (axicabtagene ciloleucel – Kite a Gilead Company) also have Accelerated Approvals for treating r/r FL. The wholesale acquisition cost (WAC) for any of the three ranges between approximately $420,000 and $450,000, not including hospitalization or any other ancillary costs. Check here for Breyanzi’s complete prescribing information.
Interchangeable Status for Hyrimoz
Prefilled syringes in 10mg/0.1mL, 20mg/0.2mL, and 80mg/0.8mL strengths of Hyrimoz® (adalimumab-adaz), Sandoz’ biosimilar for high-concentration Humira® (adalimumab), which already had been FDA approved were designated as interchangeable with Humira by the FDA on April 5, 2024. An unbranded version, adalimumab-adaz, which was approved under the same application as Hyrimoz, also are interchangeable in the selected strengths. In states that allow substitution, the included strengths of both now can be dispensed instead of Humira without contacting the prescriber for permission to substitute. Hyrimoz and adalimumab-adaz 40mg/0.4mL, while available, cannot be deemed ‘interchangeable’ until exclusivity for another interchangeable biosimilar, Simlandi® (adalimumab-ryvk) injection, 40mg/0.4mL expires in 2025. Two others, Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm) and Abrilada™ (adalimumab-afzb – Pfizer) are interchangeable with Humira’s lower strength. Adalimumab is a monoclonal antibody that inhibits tumor necrosis factor (TNF), to reduce inflammation. Most indications for the Hyrimoz products are the same as Humira’s — for treating adults who have ankylosing spondylitis (AS), hidradenitis suppurativa, plaque psoriasis, psoriatic arthritis (PsA), rheumatoid arthritis (RA) or ulcerative colitis (UC); for treating children at least two years of age who have juvenile idiopathic arthritis (JIA); and for treating patients aged six years and older for Crohn’s disease. It is given by subcutaneous (SC) injections — usually once every two weeks. For many of the adult indications, the recommended maintenance dose is 40mg, after higher loading doses. Pediatric dosing is based on the child’s weight. A boxed warning on the labels of all TNF blockers and information in Medication Guides for patients describes the increased risks of cancer and serious infections that may be associated with their use. Prospective patients should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues. Updated prescribing information for Hyrimoz is here.
MedWatch Update
Cue Health COVID-19 Tests
On May 13, 2024, the FDA advised against using COVID-19 Tests made by Cue Health. Alterations that lowered their sensitivity to the virus were made to the tests after the FDA issued emergency use authorizations (EUAs) for them in 2020 and 2021. As a result, the tests are no longer accurate – falsely registering both positive and negative results. Individuals who have tests for home and over-the-counter (OTC) use and health professionals who have tests for office use should throw them away. Retesting with a different brand may be needed for those who have COVID symptoms, but who tested negative within the last two weeks with one of the defective tests. More information is in the FDA’s notice.