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

News release

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

December 6, 2019 - Ottawa, ON - Health Canada

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

Associated links

Contacts

Media Inquiries:
Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public Inquiries:
(613) 957-2991
1-866 225-0709


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