FDA Approves Ovarian Cancer Drug with BRCA Test

Olaparib treats women with advanced ovarian cancer associated with defective BRCA genes.

Olaparib treats women with advanced ovarian cancer associated with defective BRCA genes.

The FDA today granted accelerated approval to a new drug for women with heavily pretreated advanced ovarian cancer associated with defective BRCA genes.

Olaparib (Lynparza) is a poly ADP-ribose polymerase (PARP) inhibitor that blocks enzymes involved in repairing damaged DNA.

“Today’s approval constitutes the first of a new class of drugs for treating ovarian cancer,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “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.”

Olaparib was approved with a genetic test called BRACAnalysis CDx, which is a companion diagnostic that detects mutations in the BRCA genes in blood samples from ovarian cancer patients. The BRCA genes play a role in repairing damaged DNA and helps to suppress tumor growth. The mutations from defective BRCA genes increase the chances for the development of ovarian cancer, with an estimated 10% to 15% of all ovarian cancer cases associated with these hereditary mutations.

The new test serves as a companion diagnostic to specifically identify patients with advanced ovarian cancer who may be candidates for treatment with olaparib.

Olaparib was approved following a clinical trial in which 137 participants with gBRCAm-associated ovarian cancer were treated with the drug to evaluate objective response rate (ORR), or the percentage of patients who exhibited partial shrinkage or complete disappearance of the tumor. Of those treated, 34% experienced ORR for an average of 7.9 months.

Common adverse events experienced with olaparib included nausea, fatigue, vomiting, diarrhea, dysgeusia, dyspepsia, headache, decreased appetite, nasopharyngitis, cough, arthralgia, musculoskeletal pain, myalgia, back pain, dermatitis, and abdominal pain. Serious adverse events included the development of myelodysplastic syndrome, acute myeloid leukemia, and lung inflammation.

“The approval of safe and effective companion diagnostic tests and drugs continue to be important developments in oncology,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in a press release. “We are very excited that the BRACAnalysis CDx is the FDA’s first approval of an LDT under a premarket approval application and is the first approval of an LDT companion diagnostic. The use of companion diagnostics helps bring to market safe and effective treatments specific to a patient’s needs.”

In terms of Lynparza's availability, an AstraZeneca spokesperson told Pharmacy Times in an e-mail that the company "anticipate(s) there to be approximately 5 business days between FDA response and product shipment to patients."

"While low patient volume is expected between December 22-31, 2014, due to the holidays, if a Lynparza prescription is received before product availability, Biologics, an integrated oncology management company whose pharmacy business unit is exclusively dispensing Lynparza, will proactively inform both the (health care professional) and patient about the expected December 31, 2014, product availability date," the spokesperson said. "Once we have the drug on the shelf, patients will be called for counseling by a pharmacist and next day delivery will be scheduled."