With the approval of its Herceptin-containing antibody drug conjugate Kadcyla (T-DM1), Roche/Genentech Inc.is moving closer to the goal of managing HER2-positive breast cancer patients across multiple lines of therapy.
Beyond Herceptin: Kadcyla Carries Torch Across Lines Of HER2 Therapy
Genentech’s HER2 program director Dietmar Berger shares broader plans for Kadcyla (ado-trastuzumab emtansine) following its approval in second-line mBC, and expects Herceptin will continue to play a role in the long term.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.