Most Read Articles
19 Sep 2018
In advanced-stage, newly diagnosed classical, CD30-positive Hodgkin lymphoma (HL), front-line therapy has resulted in durable remission rates in up to 70–90% of patients, although approximately 25–30% of advanced stage HL patients are refractory or relapse following first-line treatment with ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) chemotherapy.1–3 The standard of care for patients with relapsed or refractory (r/r) classical HL is salvage therapy using second-line high-dose chemotherapy (HDCT), followed by autologous haematopoietic stem cell transplant (ASCT) in eligible patients, which can induce a complete remission (CR) in about 50% of patients.4 Nevertheless, the prognosis of patients who relapse after the salvage HDCT/ASCT is exceedingly poor, with a median survival duration of approximately 1.2 years.5
09 Sep 2016
A German longitudinal study shows that Hodgkin’s lymphoma survivors experience acute and persistent fatigue regardless of tumour stage and treatment.
Natalia Reoutova, 16 Jul 2019
Reduced conditioning intensity is significantly associated with increased relapse, decreased disease-free survival (DFS), and decreased overall survival (OS) in acute myeloid leukaemia (AML) patients with measurable residual disease (MRD), a new analysis of a phase III randomized clinical trial has shown.
12 Oct 2016
Front-line treatment with rituximab plus high-dose sequential chemotherapy (R-HDS) with autologous stem-cell transplantation (ASCT) does not improve outcomes of high-risk patients with diffuse large B-cell lymphomas, a study shows.

Original New Drug Application Approvals by US FDA (1 -15 June 2018)

15 Jun 2018

New drug applications approved by US FDA as of 1-15 June 2018 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

    FULPHILA

  • Active Ingredient(s): Pegfilgrastim-JMDB
  • Strength: 6 mg/0.6 ml
  • Dosage Form: Injectable;injection
  • Company: Mylan GMBH
  • Approval Date: June 04, 2018
  • Submission Classification: Not applicable
  • Indication(s): Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
  • Approved Label: 06/04/2018(PDF)

  MOXIDECTIN
  • Active Ingredient(s): Moxidectin
  • Strength: 2 mg
  • Dosage Form: Tablet;oral
  • Company: Medicines Development for Global Health
  • Approval Date:  June 13, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older.
  • Approved Label: 06/13/2018(PDF)
LYMEPAK
  • Active Ingredient(s): Doxycycline Hyclate
  • Strength: 100 mg
  • Dosage Form: Tablet;oral
  • Company: Chartwell Pharma
  • Approval Date: June 15, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for  the treatment of early Lyme disease (as evidenced by erythema migrans) due to Borrelia burgdorferi in adults and pediatric patients 8 years of age and older weighing 45 kg and above.
  • Approved Label: 06/15/2018(PDF)
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Most Read Articles
19 Sep 2018
In advanced-stage, newly diagnosed classical, CD30-positive Hodgkin lymphoma (HL), front-line therapy has resulted in durable remission rates in up to 70–90% of patients, although approximately 25–30% of advanced stage HL patients are refractory or relapse following first-line treatment with ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) chemotherapy.1–3 The standard of care for patients with relapsed or refractory (r/r) classical HL is salvage therapy using second-line high-dose chemotherapy (HDCT), followed by autologous haematopoietic stem cell transplant (ASCT) in eligible patients, which can induce a complete remission (CR) in about 50% of patients.4 Nevertheless, the prognosis of patients who relapse after the salvage HDCT/ASCT is exceedingly poor, with a median survival duration of approximately 1.2 years.5
09 Sep 2016
A German longitudinal study shows that Hodgkin’s lymphoma survivors experience acute and persistent fatigue regardless of tumour stage and treatment.
Natalia Reoutova, 16 Jul 2019
Reduced conditioning intensity is significantly associated with increased relapse, decreased disease-free survival (DFS), and decreased overall survival (OS) in acute myeloid leukaemia (AML) patients with measurable residual disease (MRD), a new analysis of a phase III randomized clinical trial has shown.
12 Oct 2016
Front-line treatment with rituximab plus high-dose sequential chemotherapy (R-HDS) with autologous stem-cell transplantation (ASCT) does not improve outcomes of high-risk patients with diffuse large B-cell lymphomas, a study shows.