FDA Roundup, Including Latest on Avastin Hearing

The frenetic pace of oncology activity at the FDA continues, as the regulatory agency has recently approved a new drug formulation to treat prostate cancer, mandated warning label changes for cigarettes and sunscreens, and issued an opinion on whether breast implants pose a cancer risk. Media coverage has kept pace by focusing on the rapidity of cancer drug approvals and the upcoming FDA hearing on Avastin’s breast cancer indication. Here’s the latest.

FDA’s Final Avastin Judgment Approaches

In July 2010 the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12-1 to revoke Avastin’s (bevacizumab’s) metastatic breast cancer indication, due to the drug’s lack of an overall survival benefit and its unfavorable risk-benefit ratio.

At the upcoming FDA Avastin hearing, manufacturer Genentech will seek to convince ODAC to reverse course and recommend maintaining the breast indication. As the hearing approaches, the oncology community is sharply divided. Here are some recent developments concerning the hearing:

• Only 6 ODAC members will attend the hearing, 5 of whom previously voted to revoke Avastin’s breast cancer indication.
• Scientific experts speaking for Genentech will not be required to disclose their financial ties to the Avastin manufacturer or any other companies.
• The organization Freedom of Access to Medicines is planning to hold a protest rally outside the hearing (Breast Cancer Patients and Families Stand up to FDA).

FDA Outpaces European Counterpart

in New Drug Approvals

Witnesses from Genentech and the FDA’s drug division will speak on the first day of the hearing, June 28, and ODAC will make its final recommendation on June 29.A new study has shown that from 2003 to 2010, the FDA approved a greater quantity of anti-cancer drugs at a faster pace than the European Medicines Agency (EMA). The research, which appears online in the journal Health Affairs, revealed that US patients also received the treatments sooner than Europeans following regulatory approval.

Researchers reviewed 35 new cancer drug approvals and found that the FDA approved 32 in a median time of 182 days, while the EMA approved 26 in a median time of 350 days. Additionally, the 23 treatments that were approved by both agencies were on the market quicker in the United States than in Europe.

Despite the improvements in the FDA’s approval time, the overall number of new drug approvals remains low. The authors concluded that their study demonstrates that the overall paucity in new cancer treatments in the United States stems from the need for improvements in clinical research, not from regulatory delay.

Roberts SA, Allen JD, Signal EV. Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe [published online ahead of print June 2011]. Health Aff. doi:10.1377/hlthaff.2011.0231.

New Formulation Approved for

Prostate Cancer Treatment

Patients with advanced prostate cancer taking the palliative treatment Lupron Depot (leuprolide acetate for depot suspension) can now receive a 45 mg injection of the medication once every 6 months. The FDA authorized the new regimen, offering additional flexibility over the previously approved dosages of 7.5 mg (1 month), 22.5 mg (3 months), and 30 mg (4 months).

According to manufacturer Abbott, Lupron Depot suppresses testosterone production, slowing cancer cell growth and potentially alleviating pain and other side effects of advanced prostate cancer.

Abbott projects the new formulation will be available at the end of the month.

Warning Label Changes for Cigarettes and Sunscreens

As reported earlier this week on OncLive.com (FDA Mandates Graphic Cigarette Label Warnings), the FDA has mandated that cigarette manufacturers include graphic health warnings on all cigarette pack labels by September 2012. Tobacco companies are gearing up to challenge the regulation in court and according to National Public Radio correspondent Nina Totenberg (Supreme Court Hands Drug Companies Twin Wins), will be bolstered by a recent Supreme Court decision that supports the first-amendment rights of corporations.

The FDA also issued new label requirements for sunscreens which include:

• Limiting the maximum SPF value on sunscreen labeling to “SPF 50+”
• Mandating that sunscreens labeled as “Broad Spectrum” provide protection against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA)
• Including harsher warnings on non—broad spectrum products or broad spectrum sunscreens with SPF values <15: “Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

More Testing Required to Determine

Cancer Risk of Breast Implants

The new sunscreen measures will take effect by summer 2012. To read the full list of proposed sunscreen label changes, go to http://1.usa.gov/j4DjW4.The FDA issued an updated report compiling the latest research data and safety information on silicone gel-filled breast implants. The report found no link between the cosmetic procedure and breast cancer; however, federal regulators suggested further research is necessary.

“Preliminary data do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer than those conducted thus far,” the report said.