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Home Tagrisso Set for EU Approval in Early-Stage EGFRm NSCLC Following CHMP Positive Opinion; Already Approved in China

Tagrisso Set for EU Approval in Early-Stage EGFRm NSCLC Following CHMP Positive Opinion; Already Approved in China

Apr 26, 2021 23:02 CST Updated 23:02
AstraZeneca

Biopharmaceutical Manufacturer

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.


April 26, 2021 /BioValleyBIOON/ --AstraZeneca(AstraZeneca) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of the targeted anticancer drug Tagrisso (Chinese brand name: Taisisha; generic name: osimertinib) as an adjuvant (postoperative) therapy for the treatment of adult patients with early-stage (Stage IB/II/IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who have undergone complete tumor resection with curative intent. If approved, Tagrisso will be indicated forTumorin patients with EGFRm NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. The CHMP opinion will now be submitted to the European Commission (EC) for review, which is expected to issue a final decision within the next two months.

To date, Tagrisso has been approved in 15 countries worldwide for the treatment of early-stage lung cancer. In China, Tagrisso received approval from the National Medical Products Administration (NMPA) in April 2020: as an adjuvant (post-operative) therapy, with or without adjuvant chemotherapy at the physician’s discretion, for the treatment of adult patients with early-stage (Stage IB/II/IIIA) EGFR-mutated non-small cell lung cancer (EGFRm NSCLC) who have undergone complete tumor resection with curative intent. Tagrisso is indicated forTumorpatients with EGFRm NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

It is worth noting that,Tagrisso is the only targeted therapy that has demonstrated efficacy in the treatment of early-stage lung cancer in a global trial, and it is also the first such drug approved in China.. This indication was approved through the priority review program, based on the Phase 3 ADAURA trial“Unprecedented” results show: Tagrisso adjuvant therapy reduces the risk of disease recurrence or death by 80%.

Lung Cancer

Lung cancer is a devastating disease, although up to 30% of NSCLC patients mayDiagnosissufficiently early to allow for curative surgery, disease recurrence remains common in early-stage disease. According to previous data, nearly half of patients diagnosed at stage IB and more than three-quarters of those diagnosed at stage IIIA will experience recurrence within 5 years. More than one-third of lung cancer patients worldwide are in China; among NSCLC patients, approximately 40%TumorEGFR mutation present.

Dave Fredrickson, Executive Vice President of AstraZeneca and Head of the Oncology Business Unit, stated: “Currently, there are no targeted therapy options available in Europe for patients with early-stage lung cancer following surgery, and recurrence rates in the region remain unacceptably high. The CHMP’s positive opinion marks an important first step toward introducing targeted therapies for these patients, further underscoring the importance of testing all lung cancer patients prior to making any treatment decisions.”TumorThe urgency of mutation testing to ensure that as many patients as possible can benefit from innovative therapies such as Tagrisso.”

The CHMP’s positive opinion is based on the positive results from the global Phase III registrational clinical study ADAURA. The data demonstrated that Tagrisso provided a statistically significant and clinically meaningful benefit in disease-free survival (DFS) both in the primary study population of patients with Stage II and IIIA EGFR-mutated non-small cell lung cancer (NSCLC) and in patients with Stage IB–IIIA disease, who constituted a secondary endpoint cohort.

The specific data are as follows: (1) In patients with stage II and IIIA disease, DFS results showed that Tagrisso reduced the risk of disease recurrence or death by 83% (HR=0.17; 99.06% CI: 0.11-0.26; p<0.001); (2) In the overall study population of patients with stage IB-IIIA disease, DFS results showed that Tagrisso reduced the risk of disease recurrence or death by 80% (HR=0.20; 99.12% CI: 0.14-0.30; p<0.001). Consistent DFS benefits were observed across all prespecified subgroups, including Asian and non-Asian patients, regardless of prior use of adjuvant chemotherapy. The safety and tolerability profile of Tagrisso in this study was consistent with previous studies in metastatic NSCLC. The relevant study results have been published in the New England Journal of Medicine (NEJM).

Tagrisso is an oral small-molecule third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that has previously been approved in multiple countries and regions worldwide, including the United States, Japan, China, and the European Union, for: (1) first-line treatment of patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC); and (2) second-line treatment of patients with locally advanced or metastatic NSCLC harboring EGFR T790M mutation-positive status. Furthermore, Tagrisso has been approved in more than ten countries, including the United States, for the treatment of early-stage lung cancer.

This latest approval marks the third indication for Tagrisso in China, following its approvals for second-line treatment of EGFR T790M mutation-positive NSCLC and first-line treatment of EGFR-mutated NSCLC; both previous indications have been included in the National Reimbursement Drug List.

Tagrisso is a third-generation irreversible EGFR-TKI with clinical activity against central nervous system metastases. Globally, Tagrisso has treated approximately 250,000 patients.

Currently, AstraZeneca is developing Tagrisso for the treatment of patients with EGFR-mutated non-small cell lung cancer (EGFRm NSCLC) across multiple disease stages, including: treatment of stage III locally advanced unresectable disease (LAURA study), neoadjuvant treatment for resectable disease (NeoADAURA), combination with chemotherapy for metastatic disease (FLAURA2), and combination with potential novel agents to address resistance to EGFR tyrosine kinase inhibitors (TKIs) (SAVANNAH study, ORCHARD study). (Bioon.com)

Original Source: Tagrisso recommended forapproval in the EU by CHMP for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer