Clinical OMICS

MAY-JUN 2017

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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Page 20 of 47 May/June 2017 Clinical OMICs 19 M yriad Genetics is working on companion diagnostics with every major developer of poly ADP-ribose poly- merase (PARP) inhibitor cancer treatments, after agreeing to use its BRACAnalysis CDx test with Clovis Oncology's approved ovarian cancer treatment Rubraca (rucaparib). Myriad will submit a supplementary premarket approval application under its existing PMA for BRACAnalysis CDx to include Rubraca. The value of the collaboration was not disclosed. "BRACAnalysis CDx is being used because Clovis is required to use an FDA-approved germline test for BRCA as part of its post-marketing commit- ment to the FDA," Myriad spokesman Ron Rogers told Clinical OMICs. Rubraca became the second FDA-approved PARP inhib- itor on December, along with a companion diagnostic— Foundation Medicine's FoundationFocus CDxBRCA test, the first next-generation-sequencing-based test okayed by the agency. The test is designed to detect deleterious BRCA1/2 gene mutations in the tumor tissue of ovarian cancer patients. Foundation Medicine acknowledges in a Technical Information Summary that it"does not distin- guish between germline and somatic alterations." Rubraca is indicated for women with advanced ovar- ian cancer treated with two or more chemotherapies, and whose tumors have a deleterious BRCA mutation identified by an FDA-approved companion diagnostic test. Clovis is one of four PARP inhibitor developers, along with AstraZeneca, BeiGene, and Tesaro. Since 2014, BRACAnaly- sis CDx has been an approved BRCA1 and BRCA2 diag- nostic test for AstraZeneca's ovarian cancer treatment Lynparza (olaparib), the first FDA-approved PARP inhibi- tor. In April, BeiGene agreed to support development of BGB-290 with Myriad's myChoice HRD and BRACAnalysis CDx tests. myChoice HRD is designed to detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as plat- inum drugs or PARP inhibitors. Last year, Myriad said myChoice HRD suc- cessfully identified an increased num- ber of patients with ovarian cancer who may benefit from Tesaro's PARP inhibitor Zejula (niraparib), which won FDA approval on March 27. "We are in discussions with all of the pharmaceutical companies developing PARPs about myChoice HRD," Rog- ers said. In February, Myriad said BRACAnalysis CDx successfully identified HER2-negative metastatic breast cancer patients who had BRCA mutations and improved response with Lyn- parza. Myriad has not discussed timing for filing a PMA in that indication. "If approved, this would provide a substantial new test- ing opportunity with BRACAnalysis CDx," Rogers said. "Importantly, this indication could represent the first FDA approval for a PARP inhibitor outside of ovarian cancer." —Alex Philippidis Myriad Enters PARP Inhibitor CDx Collaboration with Clovis Oncology The FDA has approved Novartis's Rydapt (midostaurin) in combination with chemo- therapy for the treatment of adult patients with newly diagnosed acute myeloid leu- kemia (AML) who have a specific genetic mutation called FLT3. The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, diag- nostic from Invivoscribe Technologies. "Rydapt is the first targeted therapy to treat patients with AML, in combination with chemotherapy," said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "The ability to detect the gene mutation with a diagnostic test means doctors can identify specific patients who may benefit from this treatment." Rydapt, a kinase inhibitor, works by blocking enzymes that promote cell growth. If the FLT3 mutation is detected in blood or bone marrow samples using the LeukoStrat CDx FLT3 Mutation Assay, the patient may be eligible for treatment with Rydapt in combination with chemo- therapy. n Ovarian cancer histology OGphoto / Getty Images New AML Combination Treatment, Companion Diagnostic Gain FDA Approval

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