The United States Food and Drug Administration has signed off on a new, larger vial size for Nelarabine Injection for adult and pediatric patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
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, according to a press release by 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.” said Orlaith Ryan, CTO and Co-Founder of Shorla Oncology.
This is the second FDA approval for Shorla’s Nelarabine Injection, following the 250mg vial introduced to help solve product shortages.
