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Jylamvo is an oral liquid formulation of methotrexate originally approved in 2022 for adults with acute lymphoblastic leukemia, among other diseases.
The FDA has expanded approval of Jylamvo to include children with acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis.
The Food and Drug Administration (FDA) expanded the approval of Jylamvo (methotrexate) to include children with acute lymphoblastic leukemia, marking it as the only oral liquid formulation of methotrexate for both adults and children, according to a press release from Shorla Oncology, the drug’s manufacturer.
Of note, the expanded approval also includes the treatment of children with polyarticular juvenile idiopathic arthritis.
“This approval follows Jylamvo’s successful use in adult patients and represents a critical step forward in addressing the unmet need of pediatric care in oncology and autoimmune diseases,” Sharon Cunningham, chief executive officer of Shorla Oncology, said in the release. “We are pleased to offer a convenient, patient-friendly alternative for both adult and pediatric patients in the U.S., as we continue to develop innovative solutions for those with limited treatment options.”
Jylamvo is an anti-inflammatory and cancer oral methotrexate that comes in an orange-flavored solution, eliminating the need for splitting or crushing pills, or compounding medication into a liquid formulation, according to the release. In addition, methotrexate, per the National Cancer Institute, may stop cells from using folic acid to make DNA and may potentially kill cancer cells, in addition to lowering the body’s immune response.
Metronomic chemotherapy: also known as low-dose chemotherapy, this is treatment during which low doses of anticancer drugs are administered on a frequent or continuous regular schedule (i.e., daily or weekly) over a long period of time.
Anaphylaxis: a life-threatening allergic reaction.
Leukopenia: lower than normal number of leukocytes, a type of white blood cell.
Ulcerative stomatitis: an immune disorder that presents as ulcers and erosions in the mouth.
“For patients with chronic conditions including cancer, Jylamvo offers a convenient, palatable option for patients who may have difficulty swallowing pills,” Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology, said in the release.
Jylamvo also comes in a formulation that remains stable at room temperature for 90 days, so it does not require cold chain storage before dispensing.
“In addition to its palatable formulation, Jylamvo offers key differences over similar drugs, such as room temperature stability for three months after opening, which eliminates the need for refrigeration before dispensing and adds convenience for patients,” Rayna Herman, chief commercial officer of Shorla Oncology, said in the release.
Jylamvo was originally approved by the FDA in November 2022 for the treatment of adults with acute lymphoblastic leukemia in conjunction with a combination chemotherapy maintenance regimen, adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or with a combination chemotherapy regimen, adults with relapsed/refractory non-Hodgkin lymphoma as part of a metronomic combination chemotherapy regimen and some autoimmune diseases, according to Jylamvo’s prescribing information on the FDA’s website.
There is a warning on the labelling for Jylamvo indicating the risk for embryo-fetal toxicity, hypersensitivity reactions and severe side effects, according to the release. In particular, serious side effects including death have been reported in patients treated with methotrexate. The warning instructs care teams to closely monitor patients for infections and side effects related to the gastrointestinal tract, bone marrow, lungs, liver, kidneys and skin. Jylamvo is also contraindicated for patients with a history of severe hypersensitivity to the drug including anaphylaxis.
In the clinical trials assessing methotrexate, according to the release, some common side effects that were reported include leukopenia, ulcerative stomatitis, abdominal distress and nausea. Other side effects that were considered clinically relevant in trials included general discomfort, infection, fatigue, fever, chills and dizziness.
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