FDA news release on pertuzumab approval (perjeta)

[Lani]

FDA NEWS RELEASE
For Immediate Release: June 8, 2012
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Perjeta for type of late-stage breast cancer

The U.S. Food and Drug Administration today approved Perjeta (pertuzumab), a new anti-HER2 therapy, to treat patients with HER2-positive late-stage (metastatic) breast cancer.

Intended for patients who have not received prior treatment for metastatic breast cancer with an anti-HER2 therapy or chemotherapy, Perjeta is combined with trastuzumab, another anti-HER2 therapy, and docetaxel, a type of chemotherapy.

HER2 is a protein involved in normal cell growth. It is found in increased amounts on some types of cancer cells (HER2-positive), including some breast cancers. In these HER2-positive breast cancers, the increased amount of the HER2 protein contributes to cancer cell growth and survival.

Perjeta is a humanized monoclonal antibody, manufactured through biotechnology methods. It is administered intravenously and is believed to work by targeting a different part of the HER-protein than trastuzumab, resulting in further reduction in growth and survival of HER2-positive breast cancer cells.

Because there are production issues that potentially could affect the long-term supply of the drug, FDA limited its approval today to drug product that has not been affected by those issues. Genentech, the manufacturer of Perjeta, has committed to take steps designed to resolve these production issues in a timely manner.

“Given the need for additional treatments for metastatic breast cancer, we made the decision to approve this drug today and not to delay its availability to patients pending resolution of the production issues relating to future supply,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “Genentech is currently developing a plan to mitigate the effect on patients of any potential shortage of Perjeta.”

Breast cancer is the second leading cause of cancer-related death among women. This year an estimated 226,870 women will be diagnosed with breast cancer, and 39,510 will die from the disease. About 20 percent of breast cancers have increased amounts of the HER2 protein.

“Since trastuzumab was first approved more than a decade ago, continued research has allowed us to better understand the role HER2 plays in breast cancer,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This research provided the background to combine two targeted drugs – trastuzumab and Perjeta with docetaxel to slow disease progression in breast cancer.”

The safety and effectiveness of Perjeta were evaluated in a single clinical trial involving 808 patients with HER2-positive metastatic breast cancer who were tested prior to treatment to determine if the HER2 protein was increased. Patients were randomly assigned to receive Perjeta, trastuzumab and docetaxel or trastuzumab and docetaxel with a placebo.

The study was designed to measure the length of time a patient lived without the cancer progressing, progression-free survival (PFS). Those treated with the combination containing Perjeta had a median PFS of 18.5 months, while those treated with the combination containing placebo had a median PFS of 12.4.

The most common side effects observed in patients receiving Perjeta in combination with trastuzumab and docetaxel were diarrhea, hair loss, a decrease in infection-fighting white blood cells, nausea, fatigue, rash, and nerve damage (peripheral sensory neuropathy).

Perjeta is being approved with a Boxed Warning alerting patients and health care professionals to the potential risk of death or severe effects to a fetus. Pregnancy status must be verified prior to the start of Perjeta treatment.

The therapy was reviewed under the agency’s priority review program, which provides for an expedited six-month review of drugs that may offer major advances in treatment.

Perjeta is marketed by South San Francisco-based Genentech, a member of the Roche Group.

For more information:

FDA: Office of Hematology and Oncology Products
FDA: Approved Drugs: Questions and Answers
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

[1rarebird]

Not withstanding the availability/production issues with this drug, does the FDA approval require that orignal early stage Her2+ patients first be tested to confirm their cancer is still Her2+ before receiving Perjeta? I ask this question since I believe I read here that sometimes the breast cancer can change its expression of the Her2 receptor either over or under as it progresses.--bird

[waterdreamer]

I know that when my cancer metastasized, I had to do another biopsy to confirm that it was her2+ cancer. I ended up doing a lung biopsy, which returned necrotic tissue, so then I had to do a lymph node biopsy, which showed the cancer to be her2+++. Only then could we go ahead with treatment. Hope this helps.

[yanyan]

So far it is approved for stage 4 bc only. Whether or not you qualify for the drug depends on your her2 status at the time of disease progression.

[dchips1]

after reading the Physcians prescribing info about the way it is prescribed. Makes me think back the way tykerb was first prescribed. That you had to take xeloda with it. OOPS My doc and I decided to "Refuse " xeloda, and my insurance has been paying for Tykerb ever since. I do not have any mets other than what is in my spine at this time, But I think I want Perjeta anyway because the Her2 cancer cells are always hiding somewhere. I would like a shot at TDM-1 as well.
so the moral of the story is..... can it be prescribed and then opt out of the "chemo" portion, once it becomes available?
Or if you have been on Herceptin for 6.5 years, are we sitting on the sidelines again? Wandering thoughts from Arizona

Darita

[dchips1]

It would be interesting to see if they can use this like Herceptin in the omaya to go straight to the mets?

Peace and Prayers Darita

[hutchibk]

If I understood correctly in December, it is approved with a docetaxol, unless your doc does otherwise, which is unusual.

[jml]

I'm confused about who is an actual candidate to use Pertuzumab???
While I'm thrilled that it's gotten approved, under the current prescribing guidelines, will it be available to me, a heavily, heavily pre-treated, 10yr Stage IV Survivor, if/when I need it?

Thoughts?

Keep the Faith~

Jessica

[hutchibk]

Don't be confused. You will need it when your onc wants to use it and other things don't work anymore... better than other things that have to be combined with Taxol (or Abraxane, which I think I will push for if I ever need it). I am a 9yr survivor/7 year stage IV and also heavily pretreated, and I am thrilled to have something else in my back pocket if I ever need it.

[dchips1]

according to the FDA blablabla stuff the prescribing info say s that it is for patients whom have never gotten Herceptin or Tykerb!!

so does that mean we are stuck out in the cold again, to be able to do Perjeta and herceptin?

that would kinda of stink! especially sice my health insurance paid for the chemo and 1rst couple years of herceptin. Now I get Herceptin and Tykerb from RX Medco/accredo. So I that would be a hard one to sneak by either one!!
Darita