FDA Approves New Formulation for Cosentyx
Novartis received approval from the U.S. Food and Drug Administration (FDA) on Oct. 6, 2023, for an intravenous (IV) version of its interleukin-17A inhibitor, Cosentyx® (secukinumab). The new formulation is indicated only for treating adults who have active cases of ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), or psoriatic arthritis (PsA). The original, subcutaneous (SC) dosage form of Cosentyx is approved for all three of the same conditions as well as to treat plaque psoriasis for patients aged six years old and older and for enthesitis-related arthritis for those at least four years old. Children as young as two years old who have PsA also can be treated with the SC version. Doses of either form depend on the patient’s weight and the condition being treated. Generally, after differing numbers and strengths of loading doses, injections of either type are given once every four weeks for maintenance. Adult patients or adult caregivers of children may be able to administer SC forms of Cosentyx, but a healthcare provider should give doses of the IV form. The IV solution will be marketed in single-dose vials of 125mg/5mL to be diluted, usually in 100mL of sodium chloride 0.9%, and infused over a period of 30 minutes. The launch of the IV solution is planned for the first quarter of 2024, at a wholesale acquisition cost (WAC) of $2,115 per vial. Full prescribing information for both versions is here.
New Indication for Braftovi Plus Mektovi
On Oct. 11, 2023, Pfizer’s Braftovi® (encorafenib) capsules and Mektovi® (binimetinib) tablets were approved to treat adults who have metastatic non-small cell lung cancer (NSCLC) that have mutations in v-RAF murine sarcoma viral oncogene homolog B1 (BRAF) V600E. After the mutations are confirmed with an appropriate diagnostic test, patients will take 450mg of Braftovi once a day and 45mg of Mektovi twice a day. Both drugs are kinase inhibitors that act on different enzymes to restrict tumor growth. When used together, they delay the development of resistance to drug therapy, as well. In tandem, they also have an indication for the treatment of adults who have inoperable melanomas that have tested positive for BRAF V600E or BRAF V600K mutations and that have spread. Braftovi also is used along with the epidermal growth factor receptor (EGFR) inhibitor, Erbitux® (cetuximab – Bristol Myers Squibb) IV infusion, to treat metastatic BRAF V600E-mutated colorectal cancer (CRC) in adults. During and for several months following treatment, patients should be observed for signs of eye, heart, liver, or muscle damage. The drugs also may be associated with new cancers or blood coagulation disorders, such as blood clots or hemorrhages. Here is the current prescribing information for Braftovi; here for Mektovi.