Most Read Articles
Christina Lau, 20 Apr 2020

Hippocampal avoidance during whole-brain radiotherapy (HA-WBRT), together with memantine, better preserves cognitive function vs WBRT plus memantine in patients with brain metastases, without compromising survival, a multi-institutional phase III trial has shown.

Natalia Reoutova, 20 May 2020

Cancer patients infected with coronavirus disease 2019 (COVID-19) appear to be at higher risk of severe outcomes, including death, but cancer type and treatment serve as better predictors, according to recent research presented at the American Association for Cancer Research (AACR) 2020 Virtual Annual Meeting I.

At the time of writing, COVID-19 has spread to more than 200 countries and territories, affecting an estimated 4.5 million people and killing over 300,000. Cancer, on the other hand, is newly diagnosed in 18 million people and takes the lives of 10 million every year.

“We have invited physician scientists who are at the epicentre of the COVID-19 pandemic, taking care of patients with cancer. They gathered prospective information to understand the effects of COVID-19 on patients with cancer, are testing new treatments, and are making this knowledge available to the global research community, so we can all benefit from their experience,” said Professor Antoni Ribas from UCLA Medical Center, Los Angeles, California, US, chairperson of the COVID-19 and cancer plenary session of the meeting.

2 days ago
Case presentation: The patient is a 46-year-old Korean lady who first presented with aggravating pleuritic chest pain characterised by a stabbing pain in the chest when inhaling and exhaling. A diagnosis of non-small cell lung cancer (NSCLC) was made from computed tomography (CT)-guided needle aspiration biopsy, and the tumour was found to be epidermal growth factor receptor (EGFR) mutation-positive (exon 19 deletion). Chest imaging revealed the presence of left-sided pleural seeding nodules. The patient was treated with afatanib with partial response as best response. Ten months after starting treatment, the patient experienced disease progression.

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

15 Oct 2019
New drug applications approved by US FDA as of 01 - 15 October 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.

HEMADY
  • Active Ingredient(s): Dexamethasone
  • Strength: 20 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Dexcel Pharma
  • Approval Date: 03 October 2019
  • Submission Classification: Not available
  • Indication(s): Indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma.
  • Approved Label03 October 2019 (PDF)

AKLIEF
  • Active Ingredient(s): Trifarotene
  • Strength: 0.005%
  • Dosage Form(s) / Route(s): Cream; topical
  • Company: Galderma Research and Dev, Inc.
  • Approval Date: 04 October 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the topical treatment of acne vulgaris in patient 9 year of age and older.
  • Approved Label04 October 2019 (PDF)

BORTEZOMIB
  • Active Ingredient(s): Bortezomib
  • Strength: 3.5 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Dr. Reddy's Labs, Inc.
  • Approval Date: 04 October 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • treatment of adult patients with multiple myeloma.
    • treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy.
  • Approved Label04 October 2019 (PDF)

QUZYTTIR
  • Active Ingredient(s): Cetirizine hydrochloride
  • Strength: 10 mg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: JDP Therapeutics, Inc.
  • Approval Date: 04 October 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of acute urticaria in adults and children 6 months of age and older.
  • Approved Label04 October 2019 (PDF)

BONSITY
  • Active Ingredient(s): Teriparatide
  • Strength: 20 mcg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Pfenex, Inc.
  • Approval Date: 04 October 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • Treatment of postmenopausal women with osteoporosis at high risk for fracture.
    • Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture.
    • Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.
  • Approved Label04 October 2019 (PDF)

BEOVU
  • Active Ingredient(s): Brolucizumab-dbll
  • Strength: 6 mg/0.5 mL
  • Dosage Form(s) / Route(s): Injectable; intravitreal
  • Company: Novartis Pharms Corp.
  • Approval Date: 07 October 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (AMD).
  • Approved Label07 October 2019 (PDF)

SCENESSE
  • Active Ingredient(s): Afamelanotide
  • Strength: 16 mg
  • Dosage Form(s) / Route(s): Implant; subcutaneous
  • Company: Clinuvel, Inc.
  • Approval Date: 08 October 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
  • Approved Label08 October 2019 (PDF)

FLUORODEOXYPHENYLALANINE ([18F]-DOPA)
  • Active Ingredient(s): Fluorodeoxyphenylalanine
  • Strength: 185 MBq
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Feinstein
  • Approval Date: 10 October 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations.
  • Approved Label10 October 2019 (PDF)

REYVOW
  • Active Ingredient(s): Lasmiditan succinate
  • Strength: 50 mg; 100 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Eli Lilly and Co.
  • Approval Date: 11 October 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the acute treatment of migraine with or without aura in adults.
  • Approved Label11 October 2019 (PDF)

SECUADO
  • Active Ingredient(s): Asenapine
  • Strength: 3.8 mg; 5.7 mg; 7.6 mg
  • Dosage Form(s) / Route(s): System; transdermal
  • Company: Hisamitsu Pharm, Co.
  • Approval Date: 11 October 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Not available
  • Approved Label: Not available
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Most Read Articles
Christina Lau, 20 Apr 2020

Hippocampal avoidance during whole-brain radiotherapy (HA-WBRT), together with memantine, better preserves cognitive function vs WBRT plus memantine in patients with brain metastases, without compromising survival, a multi-institutional phase III trial has shown.

Natalia Reoutova, 20 May 2020

Cancer patients infected with coronavirus disease 2019 (COVID-19) appear to be at higher risk of severe outcomes, including death, but cancer type and treatment serve as better predictors, according to recent research presented at the American Association for Cancer Research (AACR) 2020 Virtual Annual Meeting I.

At the time of writing, COVID-19 has spread to more than 200 countries and territories, affecting an estimated 4.5 million people and killing over 300,000. Cancer, on the other hand, is newly diagnosed in 18 million people and takes the lives of 10 million every year.

“We have invited physician scientists who are at the epicentre of the COVID-19 pandemic, taking care of patients with cancer. They gathered prospective information to understand the effects of COVID-19 on patients with cancer, are testing new treatments, and are making this knowledge available to the global research community, so we can all benefit from their experience,” said Professor Antoni Ribas from UCLA Medical Center, Los Angeles, California, US, chairperson of the COVID-19 and cancer plenary session of the meeting.

2 days ago
Case presentation: The patient is a 46-year-old Korean lady who first presented with aggravating pleuritic chest pain characterised by a stabbing pain in the chest when inhaling and exhaling. A diagnosis of non-small cell lung cancer (NSCLC) was made from computed tomography (CT)-guided needle aspiration biopsy, and the tumour was found to be epidermal growth factor receptor (EGFR) mutation-positive (exon 19 deletion). Chest imaging revealed the presence of left-sided pleural seeding nodules. The patient was treated with afatanib with partial response as best response. Ten months after starting treatment, the patient experienced disease progression.