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.

3 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 (16 - 30 April 2020)

29 Apr 2020
New drug applications approved by US FDA as of 16 - 30 April 2020 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.

EMERPHED
  • Active Ingredient(s): Ephedrine sulfate
  • Strength: 50 mg/10 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Nexus Pharms
  • Approval Date: 17 April 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
  • Approved Label17 April 2020 (PDF)

TUKYSA
  • Active Ingredient(s): Tucatinib
  • Strength: 50 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Seattle Genetics
  • Approval Date: 17 April 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable  or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
  • Approved Label17 April 2020 (PDF)

PEMAZYRE
  • Active Ingredient(s): Pemigatinib
  • Strength: 4.5 mg; 9 mg; 13.5 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Incyte Corp.
  • Approval Date: 17 April 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults with previously treated, unresectable locally advances or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
  • Approved Label17 April 2020

TRODELVY
  • Active Ingredient(s): Sacituzumab govitecan-hziy
  • Strength: 180 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Immuomedics, Inc.
  • Approval Date: 22 April 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.
  • Approved Label22 April 2020 (PDF)

ONGENTYS
  • Active Ingredient(s): Opicapone
  • Strength: 25 mg; 50 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Neurocrine
  • Approval Date: 24 April 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes.
  • Approved Label24 April 2020 (PDF)

MILPROSA
  • Active Ingredient(s): Progesterone
  • Strength: 1.78 g
  • Dosage Form(s) / Route(s): Ring; vaginal
  • Company: Ferring Pharmaceutical, Inc.
  • Approval Date: 29 April 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.
  • Approved Label29 April 2020 (PDF)
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
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.

3 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.