Most Read Articles
Elaine Soliven, 28 Jun 2019
Adjuvant treatment with ipilimumab significantly improved overall survival (OS) among patients with resected high-risk melanoma compared with high-dose interferon-α2b (HDI*), according to final results of the North American Intergroup E1609** trial presented at ASCO 2019.
Elaine Soliven, 18 Jun 2019
Neoadjuvant treatment with trastuzumab emtansine (T-DM1) plus pertuzumab led to an elevated risk of 3-year event-free survival (EFS) events in patients with HER2-positive breast cancer, according to a secondary analysis of the KRISTINE* trial presented at ASCO 2019.
Audrey Abella, 14 Jun 2019
The taxane-based TPEx regimen demonstrated encouraging overall survival (OS) benefit for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) compared with the fluorouracil (5FU)-based EXTREME regimen, according to the results of the TPExtreme* trial presented at ASCO 2019.
Audrey Abella, 11 Jul 2019
Augmenting the triple chemotherapeutic regimen FOLFOXIRI* with bevacizumab demonstrated favourable efficacy regardless of age and gender in patients with unresectable metastatic colorectal cancer (mCRC), according to data presented at the ESMO World Congress on Gastrointestinal Cancer (ESMO GI) 2019.

Original New Drug Application Approvals by US FDA (01 - 15 June 2019)

15 Jun 2019
New drug applications approved by US FDA as of 01 - 15 June 2019 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.

NUCALA
  • Active Ingredient(s): Mepolizumab
  • Strength: 100 mg/mL
  • Dosage Form(s) / Route(s): Injectable; subcutaneous
  • Company: GlaxoSmithKline
  • Approval Date: 06 June 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for:
    • Add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
    • The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). 
  • Approved Label06 June 2019 (PDF)

POLIVY
  • Active Ingredient(s): Polatuzumab vedotin-piiq
  • Strength: 140 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Genentech
  • Approval Date: 10 June 2019
  • Submission Classification: Not available
  • Indication(s): Indicated in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies. 
  • Approved Label10 June 2019 (PDF)

KANJINTI
  • Active Ingredient(s): Trastuzumab-anns
  • Strength: 420 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Amgen, Inc.
  • Approval Date: 13 June 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for:
    • The treatment of HER2 overexpressing breast cancer.
    • The treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
  • Approved Label13 June 2019 (PDF)
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Most Read Articles
Elaine Soliven, 28 Jun 2019
Adjuvant treatment with ipilimumab significantly improved overall survival (OS) among patients with resected high-risk melanoma compared with high-dose interferon-α2b (HDI*), according to final results of the North American Intergroup E1609** trial presented at ASCO 2019.
Elaine Soliven, 18 Jun 2019
Neoadjuvant treatment with trastuzumab emtansine (T-DM1) plus pertuzumab led to an elevated risk of 3-year event-free survival (EFS) events in patients with HER2-positive breast cancer, according to a secondary analysis of the KRISTINE* trial presented at ASCO 2019.
Audrey Abella, 14 Jun 2019
The taxane-based TPEx regimen demonstrated encouraging overall survival (OS) benefit for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) compared with the fluorouracil (5FU)-based EXTREME regimen, according to the results of the TPExtreme* trial presented at ASCO 2019.
Audrey Abella, 11 Jul 2019
Augmenting the triple chemotherapeutic regimen FOLFOXIRI* with bevacizumab demonstrated favourable efficacy regardless of age and gender in patients with unresectable metastatic colorectal cancer (mCRC), according to data presented at the ESMO World Congress on Gastrointestinal Cancer (ESMO GI) 2019.