Policy & Regulation
European CHMP Adopts Positive Opinion for Kite's KTE-X19 for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
20 October 2020 - - The European Medicines Agency Committee for Medicinal Products for Human Use has issued a positive opinion on US-based pharmaceutical company Gilead's (NASDAQ: GILD) Kite subsidiary's Marketing Authorization Application for KTE-X19, a chimeric antigen receptor T cell therapy, as a potential treatment for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton's tyrosine kinase inhibitor, the company said.

The CHMP opinion recommends conditional authorization, an early access pathway for medicines that show promising therapeutic effects, but for which comprehensive data are not available.

The CHMP recommendation was based on the positive benefit-risk for KTE-X19 as demonstrated from the safety and efficacy results of the ZUMA-2 trial.

Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma that arises from cells originating in the "mantle zone" of the lymph node and predominantly affects men over the age of 60.

Patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton's tyrosine kinase have a poor prognosis, with a median overall survival of 6 to 10 months.

In Europe, it is estimated that at least 7,400 people are diagnosed with mantle cell lymphoma each year.

KTE-X19 is an autologous, anti-CD19 CAR T cell therapy, an individualized method of treatment that harnesses the body's own immune system to target cancer cells.

KTE-X19 uses the XLP manufacturing process that includes T cell enrichment, a necessary step in certain B cell malignancies in which circulating lymphoblasts are a common feature.

In recognition of its potential to benefit patients with significant unmet medical need, KTE-X19 was granted Priority Medicines (PRIME) designation by the EMA.

In Europe, KTE-X19 is not yet approved and remains investigational with its efficacy and safety not established.

The European Commission will now review the CHMP recommendation and the final decision on the Marketing Authorization is expected in the coming months.

Conditional marketing authorization in Europe is initially valid for one year but can be extended or converted into an unconditional marketing authorization after the submission and assessment of additional confirmatory data.

Conditional approval is granted to a medicinal product that fulfils an unmet medical need where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required.

It requires additional monitoring and post-marketing data before full approval is granted.

The Marketing Authorization Application of KTE-X19 is supported by data from the ongoing, multinational, single arm, Phase 2, open-label ZUMA-2 pivotal trial.

The study enrolled 74 adult patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a Bruton tyrosine kinase inhibitor (ibrutinib or acalabrutinib).

The primary endpoint was objective response rate per the Lugano Classification, defined as the combined rate of complete response and partial responses as assessed by an Independent Radiologic Review Committee. KTE-X19 was manufactured for 71 patients and administered to 68 patients.
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