Delays Plague Breast and Ovarian Cancer Research

Regulations Slow New Drugs Targeting BRCA Mutations

By Karen Iris Tucker

Published August 14, 2012, issue of August 17, 2012.
  • Print
  • Share Share
  • Single Page

(page 2 of 2)

“Patients were having to take lots of pills a day to get the appropriate dose,” said Dr. Kristin Zorn, a surgical oncologist at Magee-Womens Hospital of UPMC in Pittsburgh. Zorn is a principal investigator for a study involving Veliparib, a PARP inhibitor being developed by Abbott Laboratories. She said the ideal dose in her Phase II trial is turning out to be much higher than originally thought, but that the study is still enrolling ovarian cancer patients.

The PARP (poly ADP-ribose polymerase) enzyme fixes damage to cells, whether cancerous or not, allowing them to continue to multiply. By interfering with that repair process, PARP inhibitors such as Olaparib and Veliparib make it harder for cancer cells with an abnormal BRCA gene to repair themselves. As a result, the tumor cells accumulate DNA damage, leading to their death.

The potential benefit of PARP inhibitors for patients who carry a BRCA mutation has led to intense interest among this group. In January, breast cancer patients and their advocates were deeply disappointed when Sanofi-Aventis announced that the Phase III trial of its PARP inhibitor, Iniparib, had failed to achieve its “primary survival endpoints”— measurements at a study’s end to see if a given treatment worked. That trial focused on patients with newly diagnosed “triple negative” breast cancer, which does not respond to hormonal treatments.

“Three quarters of BRCA1 breast cancers, especially if [patients] are under the age of 50, are triple negative,” said Daly, adding that, for BRCA2 carriers, the numbers are about 20% to 25%.

Sue Friedman, a 14-year survivor of hereditary breast cancer, is executive director of Facing Our Risk of Cancer Empowered (FORCE), which advocates for those affected by hereditary breast and ovarian cancer. She has watched with frustration the fitful progress of these drugs and contends their stymied path to approval stems, in part, from the failure to design a trial focused solely on BRCA carriers, whom researchers initially had in mind when developing the medicines.

This decision “may have contributed to the fact that the larger studies didn’t meet their primary endpoint,” said Friedman. “My concern is that it may be a while before other companies will develop a new therapy for this community because of the challenges that have been facing PARP inhibitors.”

Zorn, however, contends that large-scale studies with both BRCA carriers and non-carriers will yield the greatest dividends. “We don’t know that the population with BRCA mutations is the only one that benefits from PARPs. We all win if we identify the largest possible group of patients who benefit from a practical standpoint; a pharma company is less likely to pursue FDA approval if only a small select group of patients are candidates.”

She continues to be optimistic about the research, particularly in its value for ovarian cancer, a disease for which there is no effective maintenance medicine since patients invariably become resistant to the treatments. Every year nearly 14,000 women in the U.S. die of the disease.

“Although the path to approval has become much more complicated,” said Zorn, “the value of what we have learned is undiminished.”

Karen Iris Tucker is a freelancer who writes about health, culture and entertainment.Contact her at feedback@forward.com


The Jewish Daily Forward welcomes reader comments in order to promote thoughtful discussion on issues of importance to the Jewish community. In the interest of maintaining a civil forum, The Jewish Daily Forwardrequires that all commenters be appropriately respectful toward our writers, other commenters and the subjects of the articles. Vigorous debate and reasoned critique are welcome; name-calling and personal invective are not. While we generally do not seek to edit or actively moderate comments, our spam filter prevents most links and certain key words from being posted and The Jewish Daily Forward reserves the right to remove comments for any reason.





Find us on Facebook!
  • Can you relate?
  • The Forverts' "Bintel Brief" advice column ran for more than 65 years. Now it's getting a second life — as a cartoon.
  • Half of this Hillel's members believe Jesus was the Messiah.
  • Vinyl isn't just for hipsters and hippies. Israeli photographer Eilan Paz documents the most astonishing record collections from around the world:http://jd.fo/g3IyM
  • Could Spider-Man be Jewish? Andrew Garfield thinks so.
  • Most tasteless video ever? A new video shows Jesus Christ dying at Auschwitz.
  • "It’s the smell that hits me first — musty, almost sweet, emanating from the green felt that cradles each piece of silver cutlery in its own place." Only one week left to submit! Tell us the story of your family's Jewish heirloom.
  • Mazel tov to Chelsea Clinton and Marc Mezvinsky!
  • If it's true, it's pretty terrifying news.
  • “My mom went to cook at the White House and all I got was this tiny piece of leftover raspberry ganache."
  • Planning on catching "Fading Gigolo" this weekend? Read our review.
  • A new initiative will spend $300 million a year towards strengthening Israel's relationship with the Diaspora. http://jd.fo/q3Iaj Is this money spent wisely?
  • Lusia Horowitz left pre-state Israel to fight fascism in Spain — and wound up being captured by the Nazis and sent to die at Auschwitz. Share her remarkable story — told in her letters.
  • Vered Guttman doesn't usually get nervous about cooking for 20 people, even for Passover. But last night was a bit different. She was cooking for the Obamas at the White House Seder.
  • from-cache

Would you like to receive updates about new stories?




















We will not share your e-mail address or other personal information.

Already subscribed? Manage your subscription.