EMA has upgraded Roche’s Alecensa

CHMP upgrades Roche’s lung cancer drug Alecensa

The European Medicines Agency (EMA) has upgraded Roche’s Alecensa (Alectinib) from second-line to first-line treatment for patients with locally advanced of metastasing ALK-positive non-small cell lung cancer (NSCLC).

At the same time, the Committee for Medicinal Products for Human Use (CHMP) switched the marketing authorisation for the kinase blocker from conditional to full approval. According to the EMA’s EPAR, Alecensa now serves as „monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)“.

Originally, the ALK- and RET inhibitor was indicated for patients intolerant or treatment-resistant to crizotinib (Xalkori, Pfizer Inc.). Last year, Roche presented data demonstrating superiority of alectinib over crizotinib. For the first half of 2017, Roche reported revenues of CHF 148.0m. In that period in the US and Japanese markets, Alecensa generated revenues of CHF 73.0m (+6%) and CHF 65.0m.

Alectinib (ATC L01XE36), a substrate of Cyp3A4,  is a cytostatic that, stops cancer proliferation through apoptosis. Half-life is 32.5 hours. The drug is contra-indicated for persons experiencing hypersensitivity reactions to the active compound.

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