FDA approved abiraterone acetate (Zytiga, Janssen Biotech Inc.) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC). More Information.
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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 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 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.
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).
On 21 December the FDA granted regular approval to hydroxyurea (Siklos®, Addmedica) for the reduction in frequency of painful crises and the need for blood transfusions in paediatric sickle cell anaemia patients ≥2 years of age with recurrent moderate to severe painful crises.
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 20 December 2017, the FDA granted regular approval to pertuzumab (Perjeta®, Roche/Genentech) for use with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer and a high recurrence risk.
On 19 December 2017, the FDA granted regular approval to cabozantinib (Cabometyx®, Exelixis) for treatment of patients with advanced renal cell carcinoma (RCC).
On 19 December 2017, the FDA granted accelerated approval to bosutinib (Bosulif®, Pfizer) for treatment of patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML).
On 1 December 2017, the FDA approved Ogivri® (trastuzumab-dkst, Mylan) as a biosimilar to Herceptin® (trastuzumab, Genentech) for the treatment of patients with HER2-overexpressing breast or metastatic gastric or gastroesophageal junction adenocarcinoma.
On 30 November 2017, the FDA granted marketing approval for the FoundationOne companion diagnostic (F1CDx®, Foundation Medicine), a next generation sequencing (NGS) based in vitro diagnostic (IVD) to detect genetic mutations in 324 genes and two genomic signatures in any solid tumour.
On 16 November 2017, the FDA approved sunitinib malate (Sutent®, Pfizer) for the adjuvant treatment of adult renal cell carcinoma patients at high risk of recurrence following nephrectomy.
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 9 November 2017, the FDA granted regular approval to dasatinib (Sprycel®, Bristol-Myers Squibb) for the treatment of paediatric patients with chronic phase (CP) Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML).
On 9 November 2017, the FDA granted regular approval to brentuximab vedotin (Adcetris®, Seattle Genetics) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who underwent prior systemic therapy.
On 6 November 2017, the FDA granted regular approval to alectinib (Alecensa®, Roche/Genentech) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
On 6 November 2017, the FDA granted regular approval to vemurafenib (Zelboraf®, Roche) for the treatment of patients with Erdheim-Chester Disease (ECD) harbouring a BRAF V600 mutation.
On 31 October 2017, the FDA granted accelerated approval to acalabrutinib (Calquence®, AstraZeneca under license of Acerta Pharma BV) for treatment of adult patients with mantle cell lymphoma (MCL) and pre-treated with one or more prior therapy.
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.
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.