Entries by News Feed

FDA approved abemaciclib plus aromatase inhibitor for untreated postmenopausal women with HR-positive HER2-negative advanced or metastatic breast cancer

  FDA approved abemaciclib (VERZENIO, Eli Lilly and Company) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. More Information.

FDA approved lutetium Lu 177 dotatate for the treatment of somatostatin receptor-positive GEP-NETs

  FDA approved lutetium Lu 177 dotatate (LUTATHERA, Advanced Accelerator Applications USA, Inc.) a radiolabeled somatostatin analogue, for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumours in adults. More Information.

FDA granted regular approval to olaparib in the treatment of (suspected) deleterious germline BRCA-mutated, HER2-negative MBC

  FDA granted regular approval to olaparib tablets (Lynparza, AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting. More Information  

FDA approved a broadened indication of afatinib in the 1st-line treatment of metastatic NSCLC with non-resistant EGFR mutations

  FDA granted approval to afatinib (Gilotrif, Boehringer Ingelheim Pharmaceutical, Inc.) for a broadened indication in 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.  More Information.  

Discontinuation, post-discontinuation monitoring criteria, and guidance for treatment re-initiation in patients taking nilotinib for Ph+ CML with a sustained molecular response

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).

Nivolumab approved for melanoma with lymph node involvement or metastatic disease after resection

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.

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

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.