Along with the drug, the FDA also approved the companion diagnostic test BRACAnalysis CDx, which was developed by Myriad Genetics to detect the presence of mutations in BRCA genes in blood samples. The efficacy of BRACAnalysis CDx was validated using blood samples from patients on Study 19.
“Today’s approval constitutes the first of a new class of drugs for treating ovarian cancer,” Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. “Lynparza is approved for patients with specific abnormalities in the BRCA gene and is an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment.”
In June 2014, the FDA’s Oncologic Drugs Advisory Committee voted 11 to 2 against the approval of the agent as maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer with germline BRCA mutations. In July, the drug’s maker AstraZeneca submitted an amendment to Lynparza’s new drug application upon the FDA’s request.
Lynparza’s efficacy was based on an analysis of 137 patients with BRCA-positive ovarian cancer who had received at least three lines of chemotherapy. In this analysis, 34 percent of patients achieved an objective response for an average of 7.9 months.
“The FDA approval of Lynparza is a significant milestone for our patients as currently there are only limited treatment options available to women with ovarian cancer who carry the BRCA mutation,” Ursula A. Matulonis, director of the Gynecological Oncology Program at Dana-Farber Cancer Institute, said in a statement.
The most commonly reported adverse events associated with Lynparza included nausea, fatigue, vomiting and diarrhea. Serious side effects included the development of myelodysplastic syndrome, acute myeloid leukemia, and lung inflammation.
AstraZeneca developed Access 360, a specialty pharmacy responsible for dispensing the drug, to assist patients with paying for the treatment. The program will verify patients’ insurance coverage and refer patients to financial assistance. More information on the program can be access at myaccess360.com/patients. "Our goal is for each patient to pay no more than $50 in out-of-pocket costs per month," said a spokesperson for AstraZeneca.
An FDA review of either of the phase 3 SOLO2 or SOLO3 trial could lead to a full approval of Lynparza in ovarian cancer. SOLO2 is examining the agent as maintenance therapy, while SOLO3 is comparing Lynparza to standard chemotherapy for relapsed disease.
In November, Avastin (bevacizumab) was approved in combination with chemotherapy for patients with platinum-resistant recurrent ovarian cancer. You can read more about the Avastin approval in "FDA Approves Avastin to Treat Ovarian Cancer.")
Additional reporting by Elizabeth Whittington.