Shorla Oncology® Announces U.S. FDA Approval of Larger Vial Size for Nelarabine Intravenous Administration for the Treatment of T-cell Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma

New 375mg vial addresses critical dosing gap for adult and pediatric patients living with T-cell Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration has approved the company’s oncology drug, Nelarabine Injection, in a larger vial size, 375mg/75mL, for adult and pediatric patients with T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL). Nelarabine Injection carries a Boxed Warning. Please see Important Safety Information below and full Prescribing Information, including a Boxed Warning.

This larger vial size is the second FDA approval of Nelarabine Injection from Shorla, both using the same formulation. The first approval, for a 250mg/50mL vial, was introduced to help address ongoing product shortages in the U.S. market. Depending on the dose, the new 375mg/75mL vial offers greater dosing flexibility for pediatric patients and provides higher-dosing options for adults. Its larger volume can allow for more precise dosing based on individual treatment needs.

“We are delighted to offer this new larger vial size of Nelarabine Injection to better serve adult and pediatric patients with T-cell leukemia and lymphoma,” said Sharon Cunningham, CEO and Co-Founder of Shorla Oncology. “Both adult and pediatric patients have differing dose needs, which can make treatment preparation complex. With this FDA approval, we hope to support healthcare providers in delivering care more efficiently, reducing waste, and improving precision in managing these types of aggressive blood cancers.”

T-cell acute lymphoblastic leukemia is an aggressive blood cancer in which too many T-cell lymphoblasts (immature white blood cells) are found in the bone marrow and blood. T-ALL affects both pediatric and adult populations, yet treatment needs differ due to variation in body surface (BSA). The median age of diagnosis for pediatric T-ALL is nine years, with an average BSA of 1.07 m², which requires a 696 mg dose. The new 375mg vial’s flexibility could enable precise dosing with fewer vials. Additionally, adult patients have an average BSA of 1.7 m² and typically demand a higher nelarabine dose of approximately 2,550 mg.

“Launching Nelarabine Injection, as our first product in the U.S., was a major milestone. Expanding that footprint with a 375mg vial of Nelarabine Injection reflects our ongoing commitment to solving real-world challenges for patients with T-cell leukemia by prioritizing improvements in healthcare delivery, pharmacy workflow, and waste reduction,” said Orlaith Ryan, CTO and Co-Founder of Shorla Oncology. “This additional vial size strengthens our ability to support both clinicians and patients living with T-ALL and T-LBL, where flexibility and accuracy in dosing is important.”

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 short supply, 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 four products: Nelarabine for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens, JYLAMVO^TM for the treatment of acute lymphoblastic leukemia and other indications, IMKELDI for the treatment of Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumors (GISTs), and other indications, and TEPULYTE® for the treatment of breast and ovarian cancer.

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

Nelarabine Injection

INDICATION

Nelarabine Injection is a nucleoside metabolic inhibitor indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

IMPORTANT SAFETY INFORMATION

WARNING: NEUROLOGIC ADVERSE REACTIONS

See full prescribing information for complete boxed warning. Severe neurologic adverse reactions have been reported with the use of Nelarabine Injection. These adverse reactions have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome. (5.1) Full recovery from these adverse reactions has not always occurred with cessation of therapy with Nelarabine Injection. Monitor frequently for signs and symptoms of neurologic toxicity. Discontinue Nelarabine Injection for neurologic adverse reactions of NCI Common Toxicity Criteria for Adverse Events (CTCAE) Grade 2 or greater. (5.1)

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

• Neurologic Adverse Reactions: Severe neurologic reactions have been reported. Monitor for signs and symptoms of neurologic toxicity.
• Hematologic Reactions: Complete blood counts including platelets should be monitored regularly.
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception; and advise males to use condoms.
• Effects on Ability to Drive and Use Machines: Somnolence may occur. Advise patients to refrain from these activities until somnolence has resolved.

ADVERSE REACTIONS

The most common (≥ 20%) adverse reactions were:

• Adult: anemia, thrombocytopenia, neutropenia, nausea, diarrhea, vomiting, constipation, fatigue, pyrexia, cough, and dyspnea.
• Pediatric: anemia, neutropenia, thrombocytopenia, and leukopenia.

The most common (> 10%) neurological adverse reactions were:

• Adult: somnolence, dizziness, peripheral neurologic disorders, hypoesthesia, headache, and paresthesia.
• Pediatric: headache and peripheral neurologic disorders.

To report SUSPECTED ADVERSE REACTIONS, contact Shorla Oncology at 1-844-668-3940 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Administration in combination with adenosine deaminase (ADA) inhibitors, such as pentostatin, is not recommended.

USE IN SPECIFIC POPULATIONS

• Lactation: Advise not to breastfeed.
• Renal Impairment: Closely monitor patients with moderate or severe renal impairment for toxicities.
• Hepatic Impairment: Closely monitor patients with severe hepatic impairment for toxicities.

Please click here for full Prescribing Information, including Boxed Warning.

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