Recent FDA Approval of Ovarian Cancer Treatment Is Too Restrictive, Specialist in Gynecologic Malignancies Says in OncLive Article

Published: Monday, Apr 20, 2015
Plainsboro, NJ, April 20, 2015 -- The president of Medicine & Science at Cancer Treatment Centers of America and editor-in-chief of OncologyLive magazine argues the FDA’s recent approval of olaparib (Lynparza) for women with BRCA-mutated advanced ovarian cancer is too restrictive and should be offered to many more patients.

In an interview featured on, Maurie Markman, M.D., says clinical trial evidence indicates that some women with high-grade serous ovarian cancer who do not test positive for a BRCA mutation may also respond to olaparib, and they should have an opportunity to decide in consultation with their physicians whether the drug is appropriate for them.

“I applaud the FDA for approving the drug, but the language in the approval is far too restricted based on the data,” Markman, a specialist in gynecologic malignancies, said in an April 15 interview entitled “Ovarian Cancer Expert Says Olaparib Label Is Too Restrictive” ( “There are a variety of clinical indications one could consider that are extremely rational and that should be discussed with patients.”

Olaparib is a first-in-class inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, which are active in DNA transcription and repair. The oral agent has proved most effective against tumors with mutations in BRCA1/2, tumor suppressor genes whose best-understood role is the repair of double-strand breaks in DNA.

About OncLive is the official website for Intellisphere’s Oncology Specialty Group, which publishes Oncology & Biotech News, OncologyLive, Oncology Nursing News and Contemporary Oncology. OncLive offers oncology professionals resources and information they need to provide the best care for their patients. Intellisphere, LLC, a leading provider of healthcare publishing, research and education, is part of the Michael J. Hennessy Associates, Inc. family of businesses, based in Plainsboro, N.J. MJH also includes the acclaimed CURE Media Group, which combines science and humanity to make cancer understandable. Its flagship product is CURE™ magazine, the largest consumer publication in the U.S. focused entirely on cancer, reaching cancer patients, cancer centers and advocacy groups. To learn more, please visit

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For OncLive:

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