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Foundation Will Assist AstraZeneca in Expanding Capabilities of Cancer Drug

by | Jun 16, 2016 | Essential, Industry Buzz-lir, Laboratory Industry Report

Massachusetts-based Foundation Medicine has entered into an agreement with pharmaceutical giant AstraZeneca to develop a diagnostic assay for the cancer drug Lynparza. The agreement is the first specific step in a broader deal between the two companies announced in May. Approved by the U.S. Food and Drug Administration in 2014, Lynparza is used to treat certain victims of ovarian cancer by blocking enzymes used to repair damaged DNA. It is believed to be particularly effective in treating women who have damaged BRCA genes. The FDA approved the drug in tandem with the use of Myriad Genetics’ BRACAnalysis CDx assay. That test and the drug is specifically for treating ovarian, fallopian tube and peritoneal cancers. However, AstraZeneca would like to be able to expand the usages of its drug. It will develop a series of clinical trials using the Foundation testing platform. “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,” said Nina Mojas, AstraZeneca’s global medicine lead for Lynparza. AstraZeneca sold $94 million worth of the drug last year, but […]

Massachusetts-based Foundation Medicine has entered into an agreement with pharmaceutical giant AstraZeneca to develop a diagnostic assay for the cancer drug Lynparza.

The agreement is the first specific step in a broader deal between the two companies announced in May. Approved by the U.S. Food and Drug Administration in 2014, Lynparza is used to treat certain victims of ovarian cancer by blocking enzymes used to repair damaged DNA. It is believed to be particularly effective in treating women who have damaged BRCA genes.

The FDA approved the drug in tandem with the use of Myriad Genetics’ BRACAnalysis CDx assay. That test and the drug is specifically for treating ovarian, fallopian tube and peritoneal cancers. However, AstraZeneca would like to be able to expand the usages of its drug. It will develop a series of clinical trials using the Foundation testing platform.

“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,” said Nina Mojas, AstraZeneca’s global medicine lead for Lynparza.

AstraZeneca sold $94 million worth of the drug last year, but its ramp-up was extremely swift during calendar 2015, with virtually no patients taking the drug in January, but more than 2,500 doing so by the end of the year. The company eventually forecasts annual sales of at least $2 billion.

“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,” said Steven Kafka, Foundation Medicine’s president. “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.”

Terms of the agreement between Foundation and AstraZeneca were not disclosed.

Takeaway: Foundation Medicine is using an agreement with AstraZeneca to expand into the development of companion diagnostics.

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