The Food and Drug Administration (FDA) has approved labeling changes for Vectibix and Erbitux to reflect studies that found the two drugs are not effective in patients whose tumors have mutated KRAS.

The FDA has updated the indication and usage for Vectibix™  (panitumumab) and Erbitux® (cetuximab) to include a statement that:

Retrospective subset analyses of metastatic or advanced colorectal cancer trials have not shown a treatment benefit for ERBITUX or VECTIBIX in patients whose tumors had K-ras mutations in codon 12 or 13 and that the use of ERBITUX or VECTIBIX is not recommended for the treatment of colorectal cancer with these mutations. Read the rest of this entry »

Patients being treated for the first time with chemotherapy and Avastin® (bevacizumab) do worse if Vectibix™ (panitumumab) is added to their chemotherapy.  Median time until the cancer progresses is shorter, and they have more serious side effects.

KRAS status made no difference.  Both patients with wild-type and mutated KRAS in their tumors had worse outcomes when panitumumab was part of their treatment.

The research team recommends that Vectibix not be added to chemotherapy with Avastin to treat colorectal cancer that has spread. Read the rest of this entry »

The Food and Drug Administration’s (FDA) Oncology Drug Advisory Committee (ODAC) is meeting today to discuss whether the labels for Erbitux (cetuximab) and Vectibix (panitumumab) should include a mention of KRAS testing. The discussion at the meeting will have implications for future development of companion diagnostics. C3 President Carlea Bauman will be testifying during the public comment section: Read the rest of this entry »

Nearly all patients who are treated with Vectibix™ (panitumumab) will develop an itchy skin rash that looks something like acne.  However, treating the rash preemptively  before it appears reduces its severity and lengthens the time before more serious rash appears.

During the STEPP (Skin Toxicity Evaluation Protocol with Panitumumab) trial, researchers randomized patients who were being treated with Vectibix to either preemptive skin rash management at the beginning of chemotherapy or reactive treatment once rash appeared.  After six weeks, 70 percent of patients treated preemptively had not developed grade 2 skin rash.  Sixty-two percent of the reactive group already had rash that was grade 2 or higher. Read the rest of this entry »

Concerned about whether you should have your tumor tested for a KRAS mutation?

You should discuss KRAS testing and your treatment options with your doctor

• If you are currently being treated with Erbitux® (cetuximab) or Vectibix™ (panitumumab) for colorectal cancer.
• Before beginning Erbitux or Vectibix treatment, either as single medicines or in combination with chemotherapy.
• When you are first diagnosed with advanced colon or rectal cancer and are planning a treatment strategy.

Recent research has shown that people with a certain change or mutation in the KRAS gene in their tumor do not benefit from either Erbitux or Vectibix.  This is true whether the medicine is used alone (monotherapy) or added to chemotherapy.

You can find more information about KRAS mutations, what research is saying about KRAS, decision-making about KRAS testing, and where you can be tested in the Patient Information pages of the C3 Fightcolorectalcancer.org web site. Read the rest of this entry »