Janssen Exec On Speeding Earlier Myeloma Interventions To Market With Key Biomarker

Having scored a commercial hit with Darzalex in myeloma, Janssen is looking to speed label expansions to the drug to enable it to intercept earlier in the disease. Janssen R&D executive Craig Tendler explained the importance of addressing smoldering myeloma and of recognizing minimal residual disease as a valid surrogate marker in trials.

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Janssen hopes regulators will help speed its plow with new myeloma surrogate endpoint

Since winning FDA approval in fourth-line use to treat multiple myeloma in November 2015, Darzalex (daratumumab) has won approval in the EU and elsewhere, and seen a series of label expansions establishing it as an important single-agent therapy as well as in combination with other treatments. In 2017, worldwide sales totalled $1.24bn.

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