The European Commission has approved the Novartis agent Kymriah (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Last week, FDA granted accelerated approval to Replimune Group Inc. for it’s biologic, RP1 (vusolimogene oderparepvec), following the FDA Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.
