The wealth of knowledge about genomic alterations that drive cancer has produced a variety of targeted therapies, but when presented with a newly diagnosed patient, oncologists are faced with a wide array of molecular tests to determine which drug might be the best. Foundation Medicine Inc. has developed a fully informative genomic profile that sequences DNA extracted from tumor tissue, identifying variations in over 200 genes that are known to be altered in human solid tumor cancers. The test produces a report that highlights “actionable” genomic alterations and links them to approved drugs known to be effective against the cancer’s genetic profile, or to appropriate clinical trials of targeted therapies in development.
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
Neurocrine reports new details of positive Phase II results in schizophrenia and a favorable safety and cardiovascular profile for its first-in-class oral M4 agonist, now moving to Phase III trials.
Astellas will pay $130m up front for near-global rights to a Phase I/II antibody-drug conjugate that will add to its portfolio of CLDN.18.2-targeted drugs, including Vyloy.