FDA Panel Supports Drug for Initial Stage Breast Cancer

FDA (Food and Drug Administration) backed a Roche drug for its efficacy in treating breast cancer before tumor-removing operations.

 Thirteen votes were received in favor by the FDA panel, with one absentee.  This is the first drug that has the ability to eradicate or cut the cancerous tumors prior to surgery.

 Roche's Genentech unit conducted a test on 417 women by treating them with Perjeta in different combinations as initial treatment. The women treated with Perjeta were found to have 18 percent greater chances of being cured from cancer after 12 weeks in comparison to women who were prescribed the formerly followed medicine combinations.

Thirty nine percent of women treated with Perjeta combined with Herceptin, another Genentech drug, and standard chemotherapy, attained undetectable cancer levels. Only 21 percent of women experienced the same results from taking Herceptin and chemotherapy alone. All women underwent standard breast surgery to cut out any tumors. Genentech stated that this surgery allowed the researchers to verify the absence or presence of cancer.

Perjeta is already approved for treatment of metastatic cancer (cancer which spreads to other parts of the body). Genentech is aiming to get permission to  market this drug as a first step toward treatment of this grave ailment.

Medics expect this medicine will help in reducing the tumor and make the process of its removal easier. This drug also gives hope to avoid full mastectomy.

"We are supporting the movement of a highly-active drug for metastatic breast cancer to the first-line setting, with the hope that women with earlier stages of breast cancer will live longer and better," Dr. Mikkael Sekeres, an associate professor of medicine at the Cleveland Clinic told the Associated Press in an interview.

The panelists emphasized that Genentech needed to conduct more tests and trials to confirm Perjeta's safety and verify positive results with a larger group of participants.

The panel acknowledged the benefits of the drug outweighed the side-effects but said the earlier trials conducted by Genentech included a very small size. The conclusion based on such a small sample needed further verification. Worrisome side-effects were observed among patients consuming Perjeta, which included heart problems.

"The other side of the equation is you have to look at the benefit, and that is the introduction of an agent that may help many women prevent metastatic disease," stated Dr. Richard Pazdur, director of the FDA's office of cancer drugs.

Very positive critique of Perjeta was published by the FDA scientists earlier this week pointing toward the criteria being met by the drug for an accelerated approval. FDA will publish its final decision on October 31, 2013.

"Reducing the overall time battling the disease has an immense and dramatic effect on the financial, emotional and medical well-being of our lives," said Judy Hodges, who was diagnosed with breast cancer in 2006.