Clinical trial strategies proposed in FDA's draft guidance for co-development of drugs designed for use in combination in most cases whittle the design down to standard of care versus the combination before Phase III, offering the prospect of cutting not only development time but also clinical trial costs.
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The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.
The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.
The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.
