How to Get New Ovarian Cancer Treatment to Patients

Olaparib (Lynparza) was approved with companion diagnostic that detects mutations in BRCA genes.

Last week, the FDA granted an accelerated approval to a new drug and test 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. The treatment represents the first of a new class of drugs for treating ovarian cancer patients with specific abnormalities in the BRCA gene, while serving as an example of how a greater understanding of the disease can generate a more personalized treatment option.

“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,” Briggs Morrison, MD, executive vice president of Global Medicines Development and Chief Medical Officer at AstraZeneca, said in a press release. “It is a much needed new therapeutic option for patients with germline BRCA-mutated advanced ovarian cancer. Today’s approval also marks the first of what we hope will be a number of indications in which this medicine has the potential to improve the lives of cancer patients.”

Olaparib was approved with a genetic test called BRACAnalysis CDx, which is a companion diagnostic that detects mutations in the BRCA genes and can specifically identify patients with advanced ovarian cancer who may be treatment candidates for the drug.

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.

Integrated oncology services company Biologics Inc was tabbed by AstraZeneca to be the exclusive distribution network provider for olaparib. Biologics said it will develop unique patient care plans to support compliance, perform benefits investigation, benefits verification, and prior authorization services to streamline access to the drug and mitigate administration difficulties providers face.

Additionally, the company will facilitate copayment or coinsurance assistance for patients.

AstraZeneca representative Alisha Martin said the company antipates it will be approximately 5 business days between the FDA response and product shipment to patients. Biologics will proactively inform both the provider and patient about the expected December 31, 2014 product availability date. Once the drug is on the shelf, patients will be called for counseling by a pharmacist and next day delivery will be scheduled.

Physicians may submit prescriptions to Biologics via phone (800-850-4306), fax (800-823-4506) or eScribe by searching for Biologics within their EMR system.

• Pharmacy name: Biologics
• Street address: 120 Weston Oaks Court, Cary, NC 27513
• NCPDP: 3430369
• NPI: 1487640314

“We are thrilled to be the exclusive provider for this groundbreaking therapy,” Dan Duffy, chief business development officer at Biologics, said in a press release. “We are honored to be a part of this important launch for AstraZeneca, and look forward to helping support patients in need of this important therapy.”