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
| 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 |
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 |
| Date Authorized | Drug | Purpose |
|---|---|---|
|
August 2019 |
For children over the age of 6 and adults with high blood pressure or chest pain Easier-to-swallow liquid format |
| 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 |
For adult patients with a blood system disease called Paroxysmal Nocturnal Haemoglobinuria |
| 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 |
| 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. |
| 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.
| 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 |
| 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 |
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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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