US FDA Onc\Haem Approvals – Page 10 – Medical News Asia

Dasatinib FDA approved in paediatric patients with chronic phase Ph+ CML

9 November 2017/0 Comments/in US FDA Onc\Haem Approvals, Uncategorised/by scienterrific

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).

Brentuximab vedotin FDA approved for pre-treated primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides

9 November 2017/0 Comments/in US FDA Onc\Haem Approvals, Uncategorised/by scienterrific

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.

Alectinib FDA approved for ALK-positive metastatic NSCLC

6 November 2017/0 Comments/in US FDA Onc\Haem Approvals, Uncategorised/by scienterrific

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.

Vemurafenib FDA approved for treatment of Erdheim-Chester Disease with BRAF V600 mutation

6 November 2017/0 Comments/in US FDA Onc\Haem Approvals, Uncategorised/by scienterrific

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.

Acalabrutinib FDA approved for treatment of adult patients with pre-treated mantle cell lymphoma

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

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.

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.

Pembrolizumab approved for advanced gastric cancer

22 September 2017/0 Comments/in Gastrointestinal Cancer, US FDA Onc\Haem Approvals, Chemotherapy, Immunotherapy, Translational Research/by Stijn van den Borne, MSc

On September 22, 2017, the FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck) for use in patients with locally advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma positive for PD-L1 as determined by an FDA-approved companion diagnostic (CDx) and progressing after ≥2 prior systemic therapies, including a fluoropyrimidine- and platinum-containing regimen, and, when appropriate, HER2-targeted therapy.

Nivolumab approved for sorafenib-refractory HCC

22 September 2017/in Gastrointestinal Cancer, US FDA Onc\Haem Approvals, Immunotherapy, Targeted Therapies/by Stijn van den Borne, MSc

On September 22, 2017, the Food and Drug Administration granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Co.) for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. Approval was based on a 154-patient subgroup of CHECKMATE-040 (NCT 01658878), a multicenter, open-label trial conducted in patients with HCC and […]