dm+d

38994711000001108

New Medicines

CalquenceChronic lymphocytic leukaemia (CLL) - first line with venetoclax and obinutuzumab

Information

Calquence
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

A second generation, potent, selective Brutons (agammaglobulinaemia) tyrosine kinase inhibitor
CLL is the most common leukaemia in the Western world with an incidence of 4.2 per 100,000 per year [1].
Chronic lymphocytic leukaemia (CLL) - first line with venetoclax and obinutuzumab
Oral

CalquenceMantle cell lymphoma (MCL) - first-line

Information

Calquence
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Yes

Category

An orally administered, second generation, potent, selective Brutons (agammaglobulinaemia) tyrosine kinase inhibitor
Mantle cell lymphoma (MCL) is an aggressive B-cell non-Hodgkin lymphoma (NHL) with poor prognosis. MCL accounts for approximately 3% to 6% of new NHL cases in Western countries each year, with an annual incidence of 0.5 per 100,000 persons and an estimated prevalence of 3.5/100,000. The median age at diagnosis is 68 years, with a 3:1 male predominance [1]
Mantle cell lymphoma (MCL) - first-line
Oral

Evidence based evaluations

CalquenceRelapsed or refractory chronic lymphocytic leukaemia (CLL) in high-risk patients

Information

Calquence
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Nov 21No plans for filing and removed from pipeline; ELEVATE-RR is not considered a registrational trial [8].

Category

A highly selective and potent BTKi
CLL is the most common leukaemia in the Western world with an incidence of 4.2 per 100,000 per year. The incidence increases to >30 per 100,000 per year at an age of >80 years. The median age at diagnosis is 72 years. About 10% of CLL patients are reported to be younger than 55 years [1].
Relapsed or refractory chronic lymphocytic leukaemia (CLL) in high-risk patients
Oral