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Calquence Recommended by CHMP for First-Line and Relapsed/Refractory CLL Treatment in the EU, Marking a Chemotherapy-Free Era

Jul 27, 2020 17:00 CST Updated 17:00
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.


July 27, 2020 /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 Calquence (acalabrutinib) for the treatment of chronic lymphocyticLeukemia(CLL) adult patients, specifically: (1) as monotherapy or in combination with obinutuzumab for the treatment of previously untreated adult patients with CLL; (2) as monotherapy for the treatment of adult patients with CLL who have received at least one prior therapy. The CHMP’s positive opinion will now be reviewed by the European Commission (EC), which is expected to issue a final decision within the next two months.

CLL is the most common type of leukemia in adults. In the United States, Calquence was approved in November 2019FDAApproved for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The CHMP’s positive opinion is based on the results of two Phase III studies (ELEVATE-TN, ASCEND). These two studies respectively confirmed that, compared with standard-of-care regimens, Calquence in combination with obinutuzumab and as monotherapy significantly reduced the risk of disease progression or death in the first-line treatment of chronic lymphocytic leukemia (CLL) and in the treatment of relapsed or refractory CLL, respectively. In both studies, the safety and tolerability profile of Calquence was consistent with its known characteristics.

——The ELEVATE-TN Study:Conducted in previously untreated (treatment-naïve) patients with chronic lymphocytic leukemia (CLL), this study evaluated the efficacy and safety of Calquence monotherapy, Calquence in combination with obinutuzumab, and standard chemoimmunotherapy consisting of chlorambucil plus obinutuzumab.Results showed that, compared with the chlorambucil plus obinutuzumab combination therapy based on chemotherapy, the Calquence plus obinutuzumab combination therapy and Calquence monotherapySignificantly reduced the risks of disease progression and death by 90% and 80%, respectively.

——ASCEND Study:Conducted in patients with relapsed or refractory CLL, comparing the efficacy and safety of Calquence versus physician’s choice of IdR (rituximab + idelalisib) or BR (rituximab + bendamustine).Results showed that, compared with the IdR or BR regimens, CalquenceSignificantly reduced the risk of disease progression or death by 69%At month 12, 88% of patients in the Calquence treatment group remained progression-free, compared with 68% in the control group.

Calquence was approved in the United States in October 2017FDAAccelerated approval for marketing, with indications including: (1) adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least one therapy; (2) adult patients with CLL or SLL.

The active pharmaceutical ingredient of Calquence is acalabrutinib, a highly selective, potent, covalent Bruton’s tyrosine kinase (BTK) inhibitor that acts by irreversibly binding to and inhibiting BTK. BTK is a key regulator of the B-cell receptor (BCR) signaling pathway, is widely expressed in various types of hematologic malignancies, and is involved in B-cell proliferation, trafficking, chemotaxis, and adhesion, making it a therapeutic target for hematologic malignancies.Tumoras an important target. In preclinical studies, acalabrutinib demonstrated minimal off-target effects.

Currently, Calquence is being developed for multiple B-cell hematologic malignancies, including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma, Waldenström macroglobulinemia (WM), follicular lymphoma (FL), multiple myeloma, and other hematologic malignancies.Tumor。

Calquence shares the same mechanism of action as AbbVie/J&J’s blockbuster blood cancer drug Imbruvica (ibrutinib), the first BTK inhibitor approved globally. Since its initial approval in November 2013, Imbruvica has gained approval for up to 11 therapeutic indications across six disease areas, with global sales rising steadily. In late June this year, pharmaceutical market research firm EvaluatePharma released a report predicting that, driven by continued market penetration and an expanding number of indications, Imbruvica’s sales will reach $10.722 billion in 2026, making it the fifth best-selling drug worldwide. (Bioon.com)