Lynparza Receives New Indication
January 12, 2018 – The U.S. FDA has approved a new indication for Lynparza® (olaparib) tablets, manufactured by AstraZeneca. Lynparza is now indicated for treatment of metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer in patients who have inherited BRCA gene mutations. The presence of these mutations is determined using a companion diagnostic test.
A poly ADP-ribose polymerase (PARP) inhibitor, Lynparza works by interfering with an enzyme used by cancer cells to repair their DNA, which may help prevent these cells from restoring themselves after being damaged by chemotherapy treatments. Lynparza was originally approved for treatment of ovarian cancer, and is now the first PARP inhibitor to receive an indication for the treatment of breast cancer. It is also the first drug to have been granted a specific indication for treatment of breast cancer with the BRCA mutation present.
Recommended dosing with Lynparza for all indications is 300mg twice per day, with or without food. Lynparza tablets should not be interchanged with Lynparza capsules on a milligram-to-milligram basis, as each form has differences in dosing and bioavailability that could lead to substitution errors and overdose.
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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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.