Most Read Articles
6 days ago
Roche recently announced their targeted therapy combination pertuzumab (Perjeta®)-trastuzumab (Herceptin®) plus conventional chemotherapy for treatment of early breast cancer in those with a subtype known as HER2-positive. The combination was previously used in the metastatic breast cancer setting, where cancer had already spread. There, it was able to prolong cancer sufferers’ lives significantly. Because of its effectiveness, the two-drug combo is new available for treatment of early HER2-positive breast cancer to further reduce the risk of metastasis or cancer recurrence. HER2-positive breast cancers usually spread faster and affect younger women and make up about one quarter of all newly diagnosed breast cancers. 
29 Jan 2019
A curative strategy for smoldering multiple myeloma (SMM) that involves induction therapy with carfilzomib, lenalidomide and dexamethasone (KRd) followed by high-dose melphalan and autologous stem cell transplantation (ASCT), KRd consolidation, and maintenance with lenalidomide and dexamethasone has demonstrated promising results in a phase II trial.
29 Jan 2019
Carfilzomib in combination with dexamethasone (Kd) is effective and safe in patients with multiple myeloma (MM) relapsing on or after lenalidomide and those with lenalidomide-refractory disease, a combined analysis of carfilzomib trials has shown.
29 Jan 2019

Salvage treatment with carfilzomib, pomalidomide and dexamethasone (KPd) is effective and safe in transplant-eligible multiple myeloma (MM) patients with refractory disease or first progression on or after treatment with bortezomib and lenalidomide, according to data from patients enrolled in the EMN02 trial.

Original New Drug Application Approvals by US FDA (16 - 30 June 2018)

30 Jun 2018

New drug applications approved by US FDA as of 16-30 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.

NOCDURNA

  • Active Ingredient(s): Desmopressin Acetate
  • Strength: 27.7 mcg; 53.3 mcg
  • Dosage Form: Tablet; sublingual
  • Company: Ferring Pharms Inc
  • Approval Date: June 21, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for r the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void. 
  • Approved Label: 06/21/2018(PDF)
ABLYSINOL
  • Active Ingredient(s): Dehydrated Alcohol
  • Strength: 1 ml; 5 ml
  • Dosage Form: Injectable; injection
  • Company: Belcher Pharms LLC
  • Approval Date: June 21, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not Applicable
  • Approved Label: Not Applicable 
ZEMDRI
  • Active Ingredient(s): Plazomicin
  • Strength: 50 mg/ml
  • Dosage Form: Injectable; injection
  • Company: Achaogen Inc
  • Approval Date: June 25, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of patients 18 years of age or older with Complicated Urinary Tract Infections (cUTI) including Pyelonephritis. 
  • Approved Label: 06/25/2018(PDF)
EPIDIOLEX
  • Active Ingredient(s): Cannabidiol
  • Strength: 100 mg/ml
  • Dosage Form: Solution; oral
  • Company: GW Research Ltd
  • Approval Date: June 25, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated  of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.
  • Approved Label: 06/25/2018(PDF)
BRAFTOVI
  • Active Ingredient(s): Encorafenib
  • Strength: 50 mg; 75 mg
  • Dosage Form: Capsule; oral
  • Company: Array Biopharma Inc
  • Approval Date: June 27, 2018
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated  for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test 
  • Approved Label: 06/27/2018(PDF)
MEKTOVI
  • Active Ingredient(s): Binimetinib
  • Strength: 15 mg
  • Dosage Form: Tablet; oral
  • Company: Array Biopharma Inc
  • Approval Date: June 27, 2018
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Not applicable
  • Approved Label: Not Applicable 
Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Oncology - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
6 days ago
Roche recently announced their targeted therapy combination pertuzumab (Perjeta®)-trastuzumab (Herceptin®) plus conventional chemotherapy for treatment of early breast cancer in those with a subtype known as HER2-positive. The combination was previously used in the metastatic breast cancer setting, where cancer had already spread. There, it was able to prolong cancer sufferers’ lives significantly. Because of its effectiveness, the two-drug combo is new available for treatment of early HER2-positive breast cancer to further reduce the risk of metastasis or cancer recurrence. HER2-positive breast cancers usually spread faster and affect younger women and make up about one quarter of all newly diagnosed breast cancers. 
29 Jan 2019
A curative strategy for smoldering multiple myeloma (SMM) that involves induction therapy with carfilzomib, lenalidomide and dexamethasone (KRd) followed by high-dose melphalan and autologous stem cell transplantation (ASCT), KRd consolidation, and maintenance with lenalidomide and dexamethasone has demonstrated promising results in a phase II trial.
29 Jan 2019
Carfilzomib in combination with dexamethasone (Kd) is effective and safe in patients with multiple myeloma (MM) relapsing on or after lenalidomide and those with lenalidomide-refractory disease, a combined analysis of carfilzomib trials has shown.
29 Jan 2019

Salvage treatment with carfilzomib, pomalidomide and dexamethasone (KPd) is effective and safe in transplant-eligible multiple myeloma (MM) patients with refractory disease or first progression on or after treatment with bortezomib and lenalidomide, according to data from patients enrolled in the EMN02 trial.