On June 4, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) and AstraZeneca reported that they have entered into a definitive agreement to develop a novel companion diagnostic assay for Lynparza (olaparib) to support its global development program (Press release, Foundation Medicine, JUN 4, 2016, View Source [SID:1234513019]). The companion diagnostic will enable physicians to identify those patients most likely to benefit from AstraZeneca’s first-in-class poly ADP-ribose polymerase (PARP) inhibitor.
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Lynparza is an innovative, oral PARP inhibitor that exploits tumor DNA repair pathway deficiencies to preferentially kill cancer cells. This mode of action gives olaparib the potential for activity in a range of tumor types with DNA repair deficiencies. Lynparza is approved in the US for the treatment of patients with germline BRCA-mutated advanced ovarian cancer and in the European Union for patients with platinum-sensitive relapsed BRCA-mutated high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer.
Under the terms of the agreement, Foundation Medicine will develop and make available a regulatory approved product utilizing the Quality Systems Regulations (QSR)-compliant version of its FoundationOne comprehensive genomic profiling platform. This assay will detect multiple classes of genomic alterations across a range of genes involved in Homologous Recombination Repair (HRR). The assay, based on a scientifically selected panel of genes known to be involved in driving the HRR process, will be developed alongside the clinical program for Lynparza, as part of a coordinated drug-diagnostic regulatory strategy.
Nina Mojas, global medicine lead for Lynparza at AstraZeneca said, "This agreement supports the broad development program for our first-in-class PARP inhibitor, Lynparza. Utilizing Foundation Medicine’s leading capabilities in molecular information will help our work to assess the potential of the medicine to address unmet patient need across a number of cancers driven by DNA repair deficiencies, including and – significantly – beyond the BRCA mutations."
"Following our new master collaboration agreement with AstraZeneca, we are pleased to launch this first strategic initiative to support and advance the development of Lynparza in a number of cancers," stated Steven J. Kafka, Ph.D., president and chief operating officer for Foundation Medicine. "The work we’ve undertaken with AstraZeneca underscores the importance and potential of utilizing our rigorously validated, comprehensive profiling approach to make available to physicians an FDA-approved universal companion diagnostic solution for use with targeted medicines."