Other news includes the launches of the first generic of an ulcer drug, the antipsychotic lurasidone, an extended-release version of topiramate for migraine, and additional strengths of the cancer drug lenalidomide. Additionally, Glenmark will distribute Cediprof's generic Adderall, and the FDA has accepted Amneal’s application for a generic naloxone nasal spray.
The FDA has approved Shorla Oncology’s generic nelarabine injection to treat adult and pediatric patients one year and older with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. T-cell leukemia is an aggressive blood and bone marrow cancer that progresses quickly. While most leukemias target older people, T-cell leukemia is most common among children. The product is a generic of Novartis’s Arranon.
A spokesperson for Shorla said the company could not comment on wholesale acquisition cost at this time. In preparation for the immediate commercial launch of Nelarabine Injection, Shorla is working with its commercialization services partner, Eversana, which it announced August 2021.
A study published in the Journal of Clinical Oncology in 2019 demonstrated that the 5-year disease-free survival rates for patients with T-cell acute lymphoblastic leukemia randomly assigned to nelarabine and no nelarabine were 88.2% ± 2.4% and 82.1% ± 2.7%, respectively. Differences between disease-free survival in a four-arm comparison were significant. Patients treated with the best-performing arm, escalating-dose methotrexate without leucovorin rescue plus pegaspargase and nelarabine, had a 5-year DFS of 91%.
“Nelarabine Injection is a critical treatment for patients living with T-cell Leukemia, particularly for children with leukemia, and it is our hope that today’s approval addresses the clinical need in this patient community,” Sharon Cunningham, chief executive officer and co-founder of Shorla Oncology, said in a press release.
Other recent generic drug news includes: