Durvalumab (IMFINZI®): Follow up Approval in Canada

Durvalumab (IMFINZI®): Follow up Approval in Canada

The recent first global approval[1] of durvalumab in the US has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[2], based on the development milestones tracked in AdisInsight.[3]

In November, 2017, durvalumab (Imfinzi™), developed by AstraZeneca via Medimmune, was also approved in Canada for the treatment of advanced bladder cancer (late stage and/or metastatic disease) as monotherapy in previously treated patients (second-line or greater).[4] Continue reading “Durvalumab (IMFINZI®): Follow up Approval in Canada”

Acalabrutinib (Calquence®): First Global Approval – Downstream approach dams the ability for tumour-survival in patients with mantle cell lymphoma

Acalabrutinib (Calquence®): First Global Approval – Downstream approach dams the ability for tumour-survival in patients with mantle cell lymphoma

The recent first global approval of acalabrutinib has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2].

In October 2017, acalabrutinib (Calquence®), developed by Acerta Pharma, received its first global approval in the US for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Continue reading “Acalabrutinib (Calquence®): First Global Approval – Downstream approach dams the ability for tumour-survival in patients with mantle cell lymphoma”

Sarilumab (Kevzara™): Follow up Approval in Japan

Sarilumab (Kevzara™): Follow up Approval in Japan

The first global approval of sarilumab in Canada has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

In September 2017, sarilumab (Kavzara™) was also approved in Japan for the treatment of adult patients with rheumatoid arthritis who have had an inadequate response to conventional treatments[1].

This approval is in addition to those already granted earlier this year in the US and Europe.

For further information related to the first approval of sarilumab please visit Drugs, or to learn more about the overall development of sarilumab across all indications visit AdisInsight.