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”

When a clinical drug study fails…the importance of proper interpretation and dissemination of negative trial results

When a clinical drug study fails…the importance of proper interpretation and dissemination of negative trial results

“The first thing you feel when a trial fails is a sense of shame,” says physician Siddhartha Mukherjee. Then comes the “exhilarating — and dangerous” instinct to slice and dice the data to resurrect the drug’s potential.

Here Siddartha discusses the lure to make more of the science than is perhaps there, when stakes are high and we are desperate to find hope for patients who are out of treatment options. Continue reading “When a clinical drug study fails…the importance of proper interpretation and dissemination of negative trial results”