The FDA apparently deems an uncontrolled study acceptable – five months after saying no.
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Could RO7851624, newly into clinical trials, be RG6735?
A new phase 2/3 will enrol a broad second-line EGFR-mutant NSCLC population.
Efficacy looks better with daraxonrasib plus chemo versus monotherapy, but toxicity looms.
But first it will need to identify the optimal dose in first-line small-cell lung cancer.
So far the data, with a Car-T Legend licensed to Novartis, lag antibody approaches.
Inlexzo gets the nod in BCG-unresponsive non-muscle invasive bladder cancer, but the group has bigger plans.
Pivotal data set the stage for slightly delayed US accelerated approval filing.