Potential Mesothelioma Drug Approval Delayed Until Trial Results are Final

Cancer research is a challenging field, and medical professionals and mesothelioma patients have learned that even if one study hits an obstacle, another will be close on its heels. Last month, the U.S. Food and Drug Administration pulled the brakes on accelerated approval of an anti-cancer drug for lung cancer and mesothelioma until further results are made available.

According to an April 12 press release from Clovis Oncology, Inc, the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee recommended that the FDA wait to see results from TIGER-3, an ongoing Phase 3, randomized, controlled trial of rociletinib, before moving forward with the approval.

“We are disappointed with today’s outcome, as we believe in the strength of the data we presented for rociletinib,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We will work with the FDA to evaluate the best path forward as it continues to review our application.”

The FDA attendees voiced concern over the safety of the drug and posed the question, is “the benefit-risk profile of rociletinib favorable in the proposed population?” The committee ultimately voted 12-1 against approval and determined that the results of TIGER-3 trial be submitted before FDA makes a regulatory decision.

“I think we have well documented issues about toxicity, dosing, and metabolism that have not been completely addressed,” said ODAC chair Deborah Armstrong, MD, of Johns Hopkins in Baltimore, according to an April 12 article in MedPage Today.

Rociletinib, marketed by Clovis Oncology,Inc., is an epidermal growth factor receptor (EGFR) inhibitor that targets patients with EGFR and T790M mutations.

EGFR is a protein found on the surface of some cells to which epidermal growth factor binds, which causes the cells to divide and spread. It is found at abnormally high levels on the surface of many types of cancer cells.  According to a 2009 article in Current Drug Targets, EGFR overexpression has been shown in more than 50% of pleural mesothelioma patients, and approximately 15% of patients with lung cancer in the U.S. express EGFR mutations.

T790M is a genetic mutation responsible for EGFR-TKI treatment resistance. Research shows lung cancer patients who experience disease progression after being treated with an EGFR inhibitor often develop the T790M resistance mutation.

Pleural mesothelioma, a form of lung cancer affecting the lining of the lungs, is caused by past exposure to asbestos. There is no cure for the cancer that kills nearly 3,000 Americans each year. Lung cancer and mesothelioma treatment is similar leading the mesothelioma community to watch closely for approval of this drug.

For more information about clinical trial, see ClinicalTrials.gov.

Sources:

• from Clovis Oncology, Inc,
  https://ir.clovisoncology.com/investors-and-news/news-releases/default.aspx
• MedPage Today
  http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/57322
• Controlled Trial of Rociletinib
  https://www.onclive.com/web-exclusives/clovis-ends-development-of-rociletinib-in-lung-cancer
• from Clovis Oncology, Inc
  https://ir.clovisoncology.com/investors-and-news/news-releases/default.aspx
• FDA attendees
  http://www.fda.gov/AdvisoryCommittees/Calendar/ucm486391.htm