AstraZeneca's Lynparza garners accelerated FDA approval for ovarian cancer

The FDA announced Friday the accelerated approval of AstraZeneca's Lynparza (olaparib) for the treatment of women with advanced ovarian cancer associated with defective BRCA genes. AstraZeneca chief medical officer Briggs Morrison stated "Lynparza is an excellent example of how advances in the understanding of cancer biology can be used to develop the next generation of targeted medicines."

"Today's approval constitutes the first of a new class of drugs for treating ovarian cancer," remarked Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. The agency also cleared Myriad Genetics' BRACAnalysis CDx companion diagnostic, which will be used to detect the presence of mutations in the BRCA genes in blood samples from patients with ovarian cancer.

In June, an FDA advisory committee voted 11 to 2 that data did not support Lynparza's accelerated approval as a maintenance therapy. After the meeting, AstraZeneca submitted additional information supporting Lynparza's use for a different indication, namely in patients with ovarian cancer associated with mutations in the BRCA genes who have received three or more chemotherapy treatments.

The additional data submitted by AstraZeneca were obtained from a Phase II study of 137 participants with measurable, germline BRCA mutated advanced ovarian cancer who previously received three or more prior lines of chemotherapy. Following treatment with the therapy, an objective response rate of 34 percent was recorded, while the median duration of response was 7.9 months. Meanwhile, severe adverse events observed in the study included myelodysplastic syndromes, acute lymphoblastic leukaemia and lung inflammation.

AstraZeneca cautioned that a full review of data from either of the two ongoing studies in the SOLO Phase III programme will be needed for conversion of accelerated approval to full approval. The drugmaker noted that data from the SOLO2 trial comparing Lynparza to placebo as a maintenance treatment are expected next year, while results of the SOLO3 trial assessing the drug in comparison to standard chemotherapy for treating relapsed disease are due in 2019.

The PARP inhibitor was cleared by the European Commission on December 18 for the treatment of patients with advanced BRCA-mutated ovarian cancer. For related analysis, see ViewPoints: AstraZeneca's rescue and recovery operation hits key milestone as Lynparza approved in EU.

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