Roche’s Tecentriq, on an EU hot streak, bags 2 new lung cancer approvals


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Roche’s Tecentriq is on a roll in Europe. After picking up a green light in breast cancer last week, the immuno-oncology treatment has snagged a pair of go-aheads in lung cancer.

The European Commission on Friday approved Tecentriq, in tandem with chemo, for previously untreated non-small cell lung cancer as well as extensive-stage small cell lung cancer.

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In NSCLC, the OK will help Roche compete with market-leader Merck & Co., whose Keytruda has been dominating the lucrative field with both monotherapy and chemo-combo approvals. Late last year, Roche joined the party with an FDA approval for a cocktail of Tecentriq, chemo and fellow Roche drug Avastin, but it showed in a study dubbed Impower130 that Tecentriq and chemo alone could improve outcomes for patients without EGFR and ALK mutations.

On the small-cell side, the EC’s move will help Roche build a lead in the field. Tecentriq this year became the first drug in the PD-1/PD-L1 class to grab a nod in that arena, and the pharma giant is working to bolster its position with competition from AstraZeneca hot on its heels.

The double win follows another victory for Roche in a rival-free indication: Triple-negative breast cancer. European regulators blessed Tecentriq in that area last week, extending a head start it won in the U.S. in March. And unlike in lung cancer, where Keytruda runs the show, tough-to-treat TNBC has so far foiled Merck.

As biosimilars to blockbusters Herceptin and Avastin encroach on Roche’s territory, the drugmaker is looking to its newer drugs to chip in sales. Aside from Tecentriq, it’s also counting on hemophilia hotshot Hemlibra and multiple sclerosis standout Ocrevus to help fill the void.




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