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

Media Inquiries: Health Canada, [phone], [email protected]: Public Inquiries: [phone], 1-866 225-0709