Regulatory Decision Summary for Tecartus

The market authorization of Tecartus was based on the results of a pivotal Phase 2, single-arm, multicentre trial, in adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Tecartus was administered as a one-time single infusion following conditioning chemotherapy.

The primary efficacy endpoint was overall response rate (ORR) as assessed by an independent review committee using the International Working Group Lugano Classification. Tecartus treatment resulted in an ORR of 91% and a complete remission (CR) rate of 65%. The median duration of response (DOR) was not reached. As patients with relapsed or refractory MCL who have received two or more prior therapies and have had disease progression following treatment with a BTK inhibitor have no standard treatment option and generally poor response rates to existing therapies, the ORR, CR rate, and DOR results were considered clinically meaningful.

Tecartus can cause severe and life-threatening adverse reactions. The most common serious adverse reactions reported in the clinical trial were encephalopathy, infections, and cytokine release syndrome (CRS). CRS and neurologic adverse reactions can be life-threatening and require prompt identification and management to prevent complications or death. In the clinical trial, CRS and neurologic adverse reactions were manageable and generally reversible by utilizing management algorithms that have been included in the Tecartus Product Monograph. Tecartus can also cause serious and sometimes fatal infections. To effectively manage the risks associated with Tecartus, administration of Tecartus should only occur at specialized treatment centres under the supervision of specially trained and experienced health professionals.

Overall, considering the poor outcomes for patients with MCL who have received at least 2 prior lines of systemic therapy and relapse after, or are refractory to, BTK inhibitor treatment, Tecartus provides a treatment option with potential for durable remissions. The benefit/risk profile for Tecartus is considered favourable for the authorized indication. The sponsor is required to submit the 24-month follow-up analysis from the pivotal Phase 2 trial, and to enable the enrolment of Canadian patients in an international registry.

Health Canada granted this application priority review in accordance with the priority review policy.

For more information on Health Canadas decision, please view the Summary Basis of Decision.