On 22 December, the FDA updated the product label for nilotinib (Tasigna®, Novartis) to include discontinuation, post-discontinuation monitoring criteria, and guidance for treatment re-initiation in patients taking nilotinib for Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) who have achieved a sustained molecular response (MR 4.5).
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On 20 December 2017, the FDA granted regular approval to the anti-PD1 monoclonal antibody, nivolumab (Opdivo®, Bristol-Myers Squibb) for the adjuvant treatment of patients with melanoma with lymph node involvement or in patients with metastatic disease after complete resection. Nivolumab received prior FDA approval for the treatment of patients with unresectable or metastatic melanoma.
On 16 November 2017, the FDA granted regular approval to obinutuzumab (Gazyva®, Genentech) in combination with chemotherapy, followed by obinutuzumab monotherapy in adult patients with previously untreated stage II bulky, III, or IV follicular lymphoma (FL) patients who achieved at least a partial remission.
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.