💊FDA PHARMA TODAY

💊FDA PHARMA TODAY

Opdivo® (Nivolumab) Intravenous Infusion Approved in Taiwan for Supplemental Indication of Advanced or Recurrent Gastric Cancer or Gastro-esophageal Junction Cancer

News Release

http://www.ono.co.jp/eng/news/pdf/sm_cn180123.pdf

Astellas Receives Orphan Designation from the European Commission for Gilteritinib for the Treatment of Acute Myeloid Leukaemia (pdf 377KB)

https://www.astellas.com/en/corporate/news/pdf/eg_180123.pdf

European Commission Approves ADCETRIS® (brentuximab vedotin) for CD30-Positive Cutaneous T-Cell Lymphoma after One Prior Systemic Therapy– Providing an Innovative Treatment Option to Patients

Cambridge, Mass. and Osaka, Japan, January 22, 2018 – Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Commission (EC) extended the current conditional marketing authorization of ADCETRIS® (brentuximab vedotin) and approved ADCETRIS for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, which is expressed on skin lesions in approximately 50 percent of patients with CTCL.

The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on November 9, 2017.

https://www.takeda.com/newsroom/newsreleases/2018/european-commission-approves-adcetris-brentuximab-vedotin-for-cd30-positive-cutaneous-t-cell-lymphoma-after-one-prior-systemic-therapy-providing-an-innovative-treatment-option-to-patients/

AstraZeneca’s PARP Inhibitor Lynparza Gets Approval in Japan – January 22, 2018.

AstraZeneca AZN and partner Merck MRK announced that the Japanese Ministry of Health, Labour and Welfare has granted approval to its PARP inhibitor, Lynparza, as a maintenance therapy for relapsed ovarian cancer, irrespective of BRCA mutation status in patients who have responded to their last platinum-based chemotherapy.

Zacks.com

https://www.zacks.com/stock/news/289595/astrazenecas-parp-inhibitor-lynparza-gets-approval-in-japan?cid=CS-ZC-FT-289595