VCBeat Health Contact Us
Home Pfizer's Third-Generation ALK Inhibitor Lorviqua Receives Positive CHMP Opinion for Previously Treated ALK-Positive Advanced NSCLC in the EU

Pfizer's Third-Generation ALK Inhibitor Lorviqua Receives Positive CHMP Opinion for Previously Treated ALK-Positive Advanced NSCLC in the EU

Mar 04, 2019 19:06 CST Updated 19:06
Pfizer

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.


March 4, 2019 /BioValleyBIOON/ -- U.S. pharmaceutical giantPfizer(Pfizer) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending conditional approval of Lorviqua (lorlatinib) as a monotherapy for adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC) who have progressed after receiving alectinib or ceritinib as their first ALK-TKI therapy, or after treatment with crizotinib and at least one other ALK-TKI.

The conversion of Lorviqua’s accelerated approval to full approval will depend on a comprehensive dataset confirming a positive benefit-risk balance. The CHMP’s opinion will now be submitted to the European Commission (EC) for review, with a final decision expected within the next 2–3 months.

Lorviqua is a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) designed to overcome resistance to first- and second-generation ALK-TKIs. The drug has been approved in the United States, Canada, and Japan under the brand name Lorbrena.

The Marketing Authorization Application (MAA) for Lorviqua is based on data from the non-randomized, dose-ranging and activity-assessing, multi-cohort, multicenter Phase I/II study B7461001. This study evaluated the efficacy and safety of Lorviqua in patients with ALK-positive advanced non-small cell lung cancer (NSCLC) who had experienced disease progression after treatment with one or more ALK tyrosine kinase inhibitors (ALK-TKIs). Based on prior treatments, 229 patients were enrolled into different subgroups. The results showed an overall response rate (ORR) of 48% with Lorviqua treatment; importantly, in the subgroup of patients who had previously received two or more ALK-TKIs, the ORR increased to 57%. In this study, 69% of patients had brain metastases, among whom the intracranial response rate with Lorviqua was 60%.

Pfizer Global Product DevelopmentTumorChris Boshoff, Chief Development Officer, stated, “Addressing resistance and recurrence remains a challenge in the treatment of ALK-positive NSCLC. This opinion from the CHMP brings us one step closer to delivering Lorviqua to patients with advanced ALK-positive NSCLC in Europe, who have limited treatment options.”

Xalkori, the world’s first ALK-targeted therapy launched by Pfizer, has significantly transformed the clinical management of patients with advanced ALK-positive non-small cell lung cancer (NSCLC) since its market approval in 2011. Nevertheless, lung cancer remains the leading cause of cancer-related mortality worldwide.

Although many patients with ALK-positive NSCLC respond to initial TKI therapy, disease progression typically occurs. Furthermore, treatment options are very limited for patients who experience disease progression after receiving second-generation ALK-TKIs (such as alectinib, brigatinib, and ceritinib).

Lorviqua/Lorbrena will provide a new treatment option for patients with ALK-positive advanced NSCLC who have experienced disease progression after treatment with first- and second-generation ALK-TKIs. (Bioon.com)