The applications to the regulatory bodies in the US and the EU were based on data from the Novartis-sponsored global clinical trial programme of Kymriah in children and young adults with r/r
B-cell ALL and adult patients with r/r DLBCL, which demonstrated the efficacy and safety of Kymriah across studies, as well as the results from the pivotal Phase II JULIET clinical trial.
Kymriah became the first CAR-T cell therapy to receive regulatory approval when it was approved by the FDA in August 2017 for the treatment of patients up to 25 years of age with
B-cell precursor ALL that is refractory or in second or later relapse.
6, 7) Besides CD5, MCL expresses all other
B-cell antigens, including CD19, CD20, CD22, CD79a, CD79b, FMC-7, and PAX5.
Primary lymphomas with an increasing incidence day by day, constitute more than 8-10% of gastric malignancies, and
B-cell variant is the most common encountered type.
Dr Axel Kallies, Associate Professor David Tarlinton, Dr Stephen Nutt and colleagues made the discovery while investigating the development of
B-cell lymphomas.
The single-agent phase II study is designed to assess the antitumor activity, tolerability and pharmacokinetic profile of SGN-40 in patients with relapsed or refractory diffuse large
B-cell lymphoma.
Primary cutaneous marginal zone
B-cell lymphomas are low-grade malignancies characterized by clonal proliferation of small neoplastic B cells with a Bcl-2+, Bcl-6-, CD10-phenotype, said Dr.
A pivotal Phase 3 randomized, controlled trial was conducted in 143 patients with relapsed or refractory, low-grade or follicular NHL or transformed
B-cell NHL.
In the January NATURE MEDICINE, researchers report that a gene called NOR1 is highly active in the diffuse large
B-cell lymphoma tumors of people for whom chemotherapy has succeeded.
Novartis announced that its supplemental Biologics License Application, or sBLA, for Kymriah suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory, or r/r, diffuse large
B-cell lymphoma, or DLBCL, who are ineligible for or relapse after autologous stem cell transplant, or ASCT, has been accepted by the FDA for Priority Review.
The US Food and Drug Administration (FDA) has approved US-based Kite Pharma's chimeric antigen receptor T cell therapy, Yescarta (axicabtagene ciloleucel), intended for the treatment of relapsed or refractory large
B-cell lymphoma in adult patients who had at least two lines of systemic therapy, it was reported on Friday.
