Gilead Gets Notice of Compliance for Yescarta™ from Health Canada

Yescarta™ is positioned to join Kymriah™ as the second chimeric antigen receptor T cell (CAR-T) therapy to achieve regulatory approval in Canada, based on exciting news released this month from Gilead Sciences Canada.

CAR-T Approvals in Canada

On September 6, 2018, Novartis announced that Kymriah™ was the first chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval within Canada. Kymriah is a CD19-directed genetically modified autologous T-cell immunocellular therapy. Kymriah’s formal name is tisagenlecleucel/ CTL019.

Health Canada approved Kymriah for use in:

Pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL) who are refractory, have relapsed after allogenic stem cell transplant (SCT) or are otherwise ineligible for SCT, or have experienced second or later relapse; and
Treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma

Following in close pursuit, Gilead Sciences Canada announced on February 19, 2019, that Health Canada granted a Notice of Compliance (NOC) for Yescarta™, a CAR T cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including:

Diffuse large B-cell lymphoma (DLBCL) not otherwise specified
Primary mediastinal large B-cell lymphoma, and
High grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL)

Yescarta’s formal name is axicabtagene ciloleucel. It was approved in Canada for intravenous administration with a strength of 200,000,000 cells/bag.

Following a priority review, Health Canada has authorized YESCARTA (axicabtagene ciloleucel), a CAR T cell immunotherapy to treat patients with one type of lymphoma #cancer. https://t.co/yDmgWLQ2QL #Drugandmeddevice pic.twitter.com/F8UdisOjYD
— GovCanHealth (@GovCanHealth) February 15, 2019

What is CAR-T Cell Therapy?

Chimeric antigen receptors (CARs) are genetically engineered cells that are developed in the laboratory and infused into a patient to help in detecting and fighting cancer. The protein constructs stimulate anti-cancer T-cells, which in turn boost a patient’s immune system.

CAR-T is a type of immunotherapy where doctors collect immune cells, modify them in a laboratory, and provide them the power to easily recognize and kill cancer cells. When infused into a patient, the cells get multiplied and stay in the body as “living drugs.”

In short, CAR-T cell therapy is a type of immunotherapy that teaches T cells to recognize and destroy cancer.

CAR-T Regulatory Approvals

To date, both Yescarta™ and Kymriah™ have achieved approvals within the U.S. and European Union. Kymriah™ has also achieved approvals in Canada and Australia and is positioned to achieve approval in Japan.

In 2017, the world witnessed a historic CAR-T cell therapy approval when on August 30, 2017, Tisagenlecleucel (Kymriah) was approved by U.S. FDA for the treatment of children and young adults with acute lymphoblastic leukemia (ALL). On May 1, 2018, FDA approved Kymriah for a second indication (diffuse large B-cell lymphoma). By October 18, 2017, the FDA had granted approval for Yescarta for treating patients with relapsed/refractory diffuse large B-cell lymphoma (r/rDLBCL) and other rare large B-cell lymphomas.

In August 2018, both Kymriah and Yescarta secured approval in Europe, indicating the willingness of European regulators to usher in a new age of regenerative medicine. Novartis’ Kymriah was given marketing authorization in the EU for the treatment of blood cancers, including B-cell acute lymphoblastic leukaemia (ALL) and relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Gilead/Kite Pharma’s Yescarta was authorized as a treatment for adult patients with relapsed or refractory DLBCL and primary mediastinal large B-cell lymphoma (PMBCL).

Next, Health Canada approved Kymriah as the first CAR-T therapy in Canada in September 2018 and the Therapeutic Goods Administration (TGA) approved it as the first CAR-T therapy in Australia in December 2018. Finally, Kymriah™ is positioned for approval within Japan, as an expert panel of the Japanese Health Ministry approved the production and sales of it earlier this month. The Japanese Health Minister is expected to issue its final approval of Kymriah™ soon.

Without a doubt, CAR-T therapies are a global phenomenon, with regulatory agencies increasingly offering their support worldwide.