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Shorla Oncology Announces U.S. FDA Expanded Approval of Jylamvo (methotrexate), an Oncology and Autoimmune Drug for Pediatric Indications

CAMBRIDGE, Mass.--(BUSINESS WIRE) --Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has expanded the approval of Jylamvo (methotrexate) to include the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA). With this approval, Jylamvo is currently the only oral liquid methotrexate on the market approved for both adult and pediatric indications.

“This approval follows Jylamvo’s successful use in adult patients and represents a critical step forward in addressing the unmet needs of pediatric care in oncology and autoimmune diseases,” said Sharon Cunningham, chief executive officer of Shorla Oncology. “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 was first approved by the FDA as the only oral liquid methotrexate to treat adults with acute lymphoblastic leukemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis and severe psoriasis.

Jylamvo has an orange flavor and comes with a dedicated dosing syringe.

“For patients with chronic conditions including cancer, Jylamvo offers a convenient, palatable option for patients who may have difficulty swallowing pills,” said Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology. “At Shorla, we are committed to continuity of supply of age-appropriate formulations for patients in need.”

Rayna Herman, chief commercial officer of Shorla Oncology added, “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. We are excited to expand our portfolio of innovative therapies for underserved patient populations.”

About Jylamvo

Jylamvo is an anti-inflammatory and cancer oral methotrexate solution approved by the U.S. Food and Drug Administration for use in adult and pediatric patients with rheumatological, dermatological and oncological diseases. Jylamvo is an easy-to-administer, orange flavored solution that eliminates the need for crushing or splitting pills, or compounding into a liquid formulation. Jylamvo offers advantages because it remains stable at room temperature (68°F to 77°F) for 90 days and does not require cold chain storage pre-dispense.

About Shorla Oncology

Shorla Oncology is a privately- held, U.S. and Ireland- based commercial stage specialty pharmaceutical company established by Sharon Cunningham and Orlaith Ryan. The company has an advanced pipeline of innovative oncology drugs for orphan and pediatric cancers. Shorla is focused on indications where existing treatments are limited, in shortage or the drug applications are inadequate for the target population. The company’s growing portfolio brings accessible, affordable and life-saving treatments to patients, delivering a major contribution to patient care. Shorla currently markets two products, Nelarabine for the treatment of T-cell leukemia and Jylamvo for the treatment of acute lymphoblastic leukemia and other indications.

For further information, please visit www.shorlaoncology.com.

IMPORTANT SAFETY INFORMATION

Jylamvo is a folate analog metabolic inhibitor indicated for the:

WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, and SEVERE ADVERSE REACTIONS

  • Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Jylamvo is contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception during and after treatment with Jylamvo.
  • Jylamvo is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis.
  • Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for infections and adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue Jylamvo as appropriate.

CONTRAINDICATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

In clinical trials, common adverse reactions were: ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other clinically relevant adverse reactions were infection, malaise, fatigue, chills, fever, and dizziness.

DRUG INTERACTIONS

Drugs that Increase Methotrexate Exposure: Coadministration of methotrexate with the following products may increase methotrexate plasma concentrations, which may increase the risk of methotrexate severe adverse reactions. In some cases, the coadministration of methotrexate with these products may also subsequently reduce active metabolite formation, which may decrease the clinical effectiveness of methotrexate. Increased organ specific adverse reactions may also occur when methotrexate is coadministered with hepatotoxic or nephrotoxic products.

If coadministration cannot be avoided, monitor closely for methotrexate adverse reactions when coadministered with:

Nitrous Oxide: Coadministration of methotrexate with nitrous oxide anesthesia potentiates the effect of methotrexate on folate-dependent metabolic pathways, which may increase the risk of severe methotrexate adverse reactions. Avoid nitrous oxide anesthesia in patients receiving methotrexate. Consider alternative therapies in patients who have received prior nitrous oxide anesthesia.

Folic Acid: Coadministration of methotrexate with folic acid or its derivatives decreases the clinical effectiveness of methotrexate in patients with neoplastic diseases. Methotrexate competes with reduced folates for active transport across cell membranes. Instruct patients to take folic or folinic acid only as directed by their healthcare provider.

Advise patients and caregivers to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on published reports and methotrexate’s mechanism of action, methotrexate can cause embryo-fetal toxicity and fetal death when administered to a pregnant woman. There are no animal data that meet current standards for nonclinical developmental toxicity studies. In pregnant women with non-malignant disease, Jylamvo is contraindicated. Consider the benefits and risks of Jylamvo and risks to the fetus when prescribing Jylamvo to a pregnant patient with a neoplastic disease. Advise patients to inform their healthcare provider of a known or suspected pregnancy.

Lactation: Limited published literature report the presence of methotrexate in human milk in low amounts, with the highest breast milk to plasma concentration ratio reported to be 0.08:1. There are no data on the effects of methotrexate or its metabolites on the breastfed child or their effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, including myelosuppression, advise women not to breastfeed during treatment with Jylamvo and for 1 week after the final dose.

Females and Males of Reproductive Potential: Methotrexate can cause malformations and fetal death at doses less than or equal to the recommended clinical doses.

Pregnancy Testing - Verify the pregnancy status of females of reproductive potential prior to initiating Jylamvo.

Contraception for Females - Jylamvo can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with Jylamvo and for 6 months after the final dose of Jylamvo.

Contraception for Males - Methotrexate can cause chromosomal damage to sperm cells. Advise males with female partners of reproductive potential to use effective contraception during treatment with Jylamvo and for at least 3 months after the final dose of Jylamvo.

Female Infertility - Based on published reports of female infertility after treatment with methotrexate, advise females of reproductive potential that methotrexate can cause impairment of fertility and menstrual dysfunction during treatment with Jylamvo and after the final dose. It is not known if the infertility may be reversed in all affected females.

Male Infertility - Based on published reports of male infertility after treatment with methotrexate, advise males of reproductive potential that methotrexate can cause oligospermia or infertility during treatment with Jylamvo and after the final dose. It is not known if the infertility may be reversed in all affected males.

Pediatric Use: The safety and effectiveness of Jylamvo in pediatric patients have been established for the treatment of ALL as part of the combination chemotherapy maintenance regimen and the treatment of pJIA. No new safety signals have been observed in pediatric patients in these clinical studies.

The safety and efficacy of Jylamvo have not been established for pediatric patients in other indications.

Renal Impairment: Methotrexate elimination is reduced in patients with renal impairment. Patients with renal impairment are at increased risk for methotrexate adverse reactions. Closely monitor patients with renal impairment [creatinine clearance (CLcr) less than 90 mL/min, Cockcroft-Gault] for adverse reactions. Reduce the dosage or discontinue Jylamvo as appropriate.

Hepatic Impairment: The pharmacokinetics and safety of methotrexate in patients with hepatic impairment is unknown. Patients with hepatic impairment may be at increased risk for methotrexate adverse reactions based on the elimination characteristics of methotrexate. Closely monitor patients with hepatic impairment for adverse reactions. Reduce the dosage or discontinue Jylamvo as appropriate.

To report suspected adverse reactions, contact Shorla Oncology at 844-9-SHORLA (844-974-6752) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Source: Shorla Oncology

Jylamvo (methotrexate) FDA Approval History

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