Posted from: Tuesday, September 05, 2017 - 03:38 PM - Present

New Approvals for Lynparza

August 17, 2017 – The U.S. FDA has approved Lynparza® (olaparib), manufactured by AstraZeneca and Merck, for treatment of patients with BRCA mutated (gBRCAm) advanced ovarian cancer who have been treated with chemotherapy a minimum of three times. A poly ADP-ribose polymerase (PARP) inhibitor, Lynparza prevents cancer cells from repairing damage to their DNA caused by chemotherapy.

The FDA has also approved Lynparza as a maintenance treatment for patients who have recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers. Treatment under this indication does not depend upon BRCA status, though patients must have a complete or partial response to platinum-based chemotherapy to be eligible.

In addition to the above indications, the FDA has approved new oral tablet dosage forms in 100mg and 150mg. Previously, Lynparza was available in capsule form, which will be gradually discontinued.  However, the capsule form and tablet form are not directly interchangeable. Recommended dosing by tablet is 300mg twice daily. Lynparza tablets have already been launched.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Tuesday, December 12, 2017 - 12:10 PM.