Daiichi Sankyo Receives CHMP Positive Opinions for Two New Drug Applications in the EU

Sep 16, 2023 06:36 CST Updated 06:36

Daiichi-Sankyo

Pharmaceutical R&D Developer

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

On September 15, two new drugs from Daiichi Sankyo received simultaneous recommendations from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The CHMP supported the approval of Quizartinib in the European Union (EU) for the treatment of newly diagnosed adult patients with FLT3-ITD positive acute myeloid leukemia (AML). This drug can be used in combination with standard cytarabine and anthracycline induction therapy and cytarabine consolidation therapy, as well as a single agent for continuous treatment after consolidation. The CHMP also supported the approval of a new indication for Enhertu (fam-trastuzumab deruxtecan-nxki) in the EU, for adult patients with unresectable or metastatic HER2-positive non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy.

Quizartinib is an orally administered, selective second-generation FLT3 inhibitor. The CHMP has taken a positive stance on the results of the Phase III trial, codenamed QuANTUM-First, published in The Lancet. QuANTUM-First is a randomized, double-blind, placebo-controlled Phase III study designed to evaluate the OS benefits of Quizartinib in newly diagnosed FLT3-ITD positive AML adult patients. These patients were randomly assigned in a 1:1 ratio to receive either Quizartinib or a placebo in combination with standard cytarabine + anthracycline induction therapy and cytarabine consolidation therapy, followed by single-agent maintenance therapy post-consolidation. The primary endpoint of the study is OS, with secondary endpoints including event-free survival (EFS), complete remission rate post-induction, and composite complete remission rate, among others.

In newly diagnosed FLT3-ITD positive AML patients, compared with standard chemotherapy, the Quizartinib group reduced the risk of death by 22% (HR=0.78, 95% CI: 0.62-0.98; p=0.032). After a median follow-up of 39.2 months, the median overall survival in the Quizartinib-treated group was 31.9 months (n=268; 95% CI: 21.0-NE), compared to 15.1 months in the control group (n=271; 95% CI: 13.2-26.2).

Enhertu is an antibody-drug conjugate (ADC) targeting HER2. The CHMP has expressed a positive opinion on the primary results of the phase II trial codenamed DESTINY-Lung02. Results presented at the 2023 WCLC showed that the confirmed objective response rates (ORR) assessed by blinded independent central review (BICR) were 49.0% (95% CI: 39.0-59.1) for the 5.4mg/kg dose group and 56.0% (95% CI: 41.3-70.0) for the 6.4mg/kg dose group of intravenous trastuzumab deruxtecan.

In the 5.4mg/kg treatment group, 1 case (1.0%) of complete response (CR) and 49 cases (48.0%) of partial response (PR) were observed, while in the 6.4mg/kg treatment group, 2 cases (4.0%) of complete response and 26 patients (52.0%) with partial response were observed. The disease control rate (DCR) in the 5.4mg/kg dose group reached 93.1% (86.4-97.2), and in the 6.4mg/kg dose group, it was 92.0% (80.8-97.8). The median duration of response (DoR) in the 5.4mg/kg treatment group was 16.8 months (95% CI: 6.4-not estimable [NE]), while the median duration of response was not reached in the 6.4mg/kg treatment group (95% CI: 8.3-NE).

Ken Takeshita, MD, Global Head of Daiichi Sankyo’s R&D Division, said: "Enhertu is the first therapy to demonstrate powerful and durable tumor responses in previously treated patients with HER2-mutated advanced NSCLC, validating HER2 as a viable target for lung cancer treatment and supporting the provision of a much-needed treatment option for these patients. The CHMP opinion is a positive step forward in advancing HER2 ADC therapy for these patients, and we look forward to the decision from the European Commission."

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