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Latest From CardioMEMS, Inc.
Janssen presents highly encouraging interim results at ESMO from the CHRYSALIS study with a combination of amivantamab and lazertinib. Based on the data, the global Phase III MARIPOSA study, which will assess the combo versus blockbuster Tagrisso, will begin next month including in South Korea, home to lazertinib's originator.
The liquid-biopsy test is also a companion diagnostic for osimertinib, AstraZeneca’s drug for non-small cell lung cancer.
The companies expect the Guardant360 CDx liquid-biopsy test to identify patients who will benefit from amivantamab, Janssen’s investigational drug for non-small cell lung cancer.
The warning letter highlights validation and recordkeeping problems at the Atlanta manufacturing facility for the CardioMEMS heart failure remote monitoring system, but it is not expected to affect device availability.