International collaboration among Canadian, U.S. and Australian regulators leads to new options for the treatment of cancer

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On September 20, 2019, Health Canada authorized a new treatment for women who haveadvanced endometrial cancer through the combined use of Lenvima (lenvatinib) and Keytruda (pembrolizumab).

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Retrieved on: 
Friday, December 6, 2019 - 3:28pm
Organisation: 
Health Canada
Government of Canada
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Key Points: 
  • On September 20, 2019, Health Canada authorized a new treatment for women who haveadvanced endometrial cancer through the combined use of Lenvima (lenvatinib) and Keytruda (pembrolizumab).
  • This was the first review conducted under Project Orbis , an initiative of the U.S.Food and Drug Administration (FDA) Oncology Center of Excellence.
  • Project Orbis brings together regulators from multiple countries to review cancer drugs at the same time so that patients can receive earlier access to needed treatments.
  • Between July and November 2019, Health Canada authorized 20 new drugs and medical devices to treat a range of health issues.


International collaboration among Canadian, U.S. and Australian regulators leads to new options for the treatment of cancer

Health Canada also provides an update on approvals of new drugs and medical devices for Canadians

OTTAWA, Dec. 6, 2019 /CNW/ - Canadians want access to the latest treatments for themselves, their families and their friends— especially for cancers, rare diseases and conditions with limited treatment options.

On September 20, 2019, Health Canada authorized a new treatment for women who have advanced endometrial cancer through the combined use of Lenvima (lenvatinib) and Keytruda (pembrolizumab). This was the first review conducted under Project Orbis, an initiative of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence. Project Orbis brings together regulators from multiple countries to review cancer drugs at the same time so that patients can receive earlier access to needed treatments. The FDA, Health Canada and the Australian Therapeutic Goods Administration (TGA) collaborated on this review.

On November 21, 2019, after the second review conducted under Project Orbis, Health Canada authorized Calquence (acalabrutinib) for adults with chronic lymphocytic leukemia (CLL). This represents another treatment option for these patients. This collaborative effort with the FDA and TGA allowed for simultaneous review and therefore earlier approval of this medication for Canadians with cancer.

Building on this foundation of cooperation, Health Canada will continue to seek opportunities to work with its international partners to bring needed treatments to Canadians sooner.

Between July and November 2019, Health Canada authorized 20 new drugs and medical devices to treat a range of health issues. Health Canada works every day to give Canadians timely, safe and secure access to drugs and medical devices.

Canadians can follow @GovCanHealth on Twitter to find out when Health Canada has authorized a new drug or medical device. For people who are not yet following us, our recent authorizations are listed below.  

Drugs and medical devices authorized since July 2019

Drugs for Cancer and Rare Diseases

 

Date Authorized

Drug

Purpose

September 2019

 

Project Orbis decision

Lenvima and Keytruda

To be used together to treat certain patients with advanced endometrial cancer

 

Simultaneous accelerated review with the U.S. FDA and the Australian TGA

August 2019 (initial decision)

Calquence (acalabrutinib)

For adults with mantle cell lymphoma (MCL) who have tried at least one other therapy  

 

Drug authorization review aligned with funding decision review to provide more timely access to treatment

 

November 2019
(Project Orbis decision)

For adults with chronic lymphocytic leukemia (CLL)

 

Simultaneous accelerated review with the U.S. FDA and the Australian TGA

 

Drug authorization review aligned with funding decision review to provide more timely access to treatment

 

Pediatric Drugs

 

Date Authorized

Drug

Purpose

August 2019

pdp-Amlodipine

For children over the age of 6 and adults with high blood pressure or chest pain

 

Easier-to-swallow liquid format

 

Drugs for General Use

 


Date Authorized

Drug

Purpose

August 2019

Emgality (galcanezumab injection)

Migraine prevention for adult patients who have at least four migraine days per month

August 2019

Lokelma (sodium zirconium cyclosilicate)

For adult patients who need to lower their blood potassium to a normal level

September 2019

Ultomiris (ravulizumab)

For adult patients with a blood system disease called Paroxysmal Nocturnal Haemoglobinuria 

 

General and Plastic Surgery Devices

 

Date

Device

Purpose

October 2019

Optium DBM Gel

For patients who require bone filler

November 2019

FreeO2 Automated Oxygen Therapy Device (FreeO2)

For adults or children who are prescribed supplemental oxygen

November 2019

OptoWire III pressure guidewire

For patients who require precise blood pressure monitoring

 

Heart Health Medical Devices

 

Date Authorized

Device

Purpose

August 2019

MitraClip G4 Clip Delivery System

For cardiac patients who need mitral valve repair

August 2019

True Dilatation Balloon Valvuloplasty Catheter

For cardiac patients who need heart valve repair

November 2019

VersaCross RF Wire

To be used together with the previously licensed RF Puncture Generator for patients who require certain heart procedures

November 2019

Watchman FLX Device

For patients with Atrial Fibrillation and who are at an increased risk for stroke

November 2019

Reprocessed ViewFlex Xtra ICE Catheter

For patients who require imaging in the heart during a cardiac procedure

December 2019

Arctic Front Advance Pro Cardiac Cryoablation Catheter

For cardiac patients who need treatment for atrial fibrillation.

December 2019

Amplatzer Valvular Plug III (AVP III)

To repair heart valve leaks that develop in patients who have had valve implant procedures.

 

Medical Devices for Diagnostics

 

Date Authorized

Device

Purpose

July 2019

Procleix Zika Virus Assay

To test patients for the Zika virus

October 2019

Beckman Coulter PK7400 Automated Microplate System

For donor blood sample testing

November 2019

Virotrol Plus-R quality control

To verify the correct performance of patient blood tests for HIV and other viruses

December 2019

Alinity S System

to test blood donors for the presence of HIV and other viruses.

 

A list of Clinical Information records published since July 2019 on Health Canada's Portal for recently authorized drugs appears in the tables below. Health Canada also adds information about drugs and medical devices already on the market to the portal upon request. Beginning in 2021, the Department will also start publishing clinical information on new medical devices.

Clinical information on drugs published since July 2019

 

Publication Date

Drug

Purpose

July 2019

Esbriet

For adults with idiopathic pulmonary fibrosis (IPF), a type of lung disease

July 2019

Odefsey

For adults infected with HIV-1

July 2019

Darzalex

For the treatment of a variety of hematological malignancies (blood cancers)

August 2019

Proquad

MMRV vaccine

August 2019

Tivicay (2 publications)

For adults infected with HIV-1

August 2019

Verzenio

For women who have metastatic breast cancer

August 2019

Skyrizi

Treatment for adults who have plaque psoriasis

August 2019

Libtayo

Antibody treatment for metastatic cutaneous squamous cell carcinoma (skin cancer)

September 2019

Bavencio

Antibody treatment for metastatic Merkel cell carcinoma (skin cancer)

October 2019

Netspot

Diagnostic agent for neuroendocrine tumour detection

October 2019

Lescol

Statin to lower blood pressure

October 2019

Crestor

Statin to lower blood pressure

November 2019

Lipitor

Statin to lower blood pressure

November 2019

Zocor

Statin to lower blood pressure

November 2019

Evenity

For the treatment of osteoporosis in postmenopausal women at high risk for fracture

November 2019

Esperoct

For adults and children with hemophilia A

November 2019

Nerlynx

For the treatment of women who have early stage breast cancer that is hormone receptor positive

 

Clinical information on medical devices published since July 2019

 

Publication Date

Device

Purpose

July 2019

Juvéderm Volbella with Lidocaine

Facial filler for patients undergoing cosmetic treatments

August 2019

Mona Lisa 10 IUD

Intrauterine contraceptive device

August 2019

Gynecare Gynemesh Ps

Surgical treatment of pelvic floor disorders in women

September 2019

840 PB Ventilator

Mechanical ventilator for patients requiring assisted breathing during medical procedures

October 2019

Redexis

Dermal filler

 

Additional Health Canada Resources for Information about Drugs and Medical Devices:
Drug and medical device highlights 2018
Report a health and safety concern
Health Canada's Action Plan on Medical Devices
New safety and effectiveness reviews
The Drug and Health Product Register
MedEffect Canada
Summary safety reviews
Drug product database
Clinical Information Portal

SOURCE Health Canada