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CAR-T Axicabtagene ciloleucel FDA approved for relapsed or refractory large B-cell lymphoma

18 October 2017/0 Comments/in US FDA Onc\Haem Approvals, Uncategorised/by scienterrific

On 18 October 2017, the FDA granted regular approval to CAR-T axicabtagene ciloleucel (Yescarta®, Kite Pharma) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of prior systemic therapy. Large B-cell lymphoma includes diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Abemaciclib in combination with fulvestrant FDA approved for HR+, HER2- advanced or metastatic breast cancer progressing following endocrine therapy

28 September 2017/0 Comments/in US FDA Onc\Haem Approvals, Uncategorised/by scienterrific

On 28 September 2017, the FDA approved abemaciclib (Verzenio®, Eli Lilly and Company) in combination with fulvestrant for women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.