THOUSAND OAKS, Calif.-Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved Vectibix(TM) (panitumumab) [Remember when I said you could instantly find targeted antibodies by the name XXXX-mab? Here's another example] following priority review. Vectibix is the first entirely human monoclonal antibody for the treatment of patients with epidermal growth factor receptor- (EGFr) expressing metastatic colorectal cancer after disease progression on, or following fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens, e.g., NOT TREATABLE.
The FDA approval of Vectibix was based on a progression-free survival endpoint [not getting any worse]. Vectibix is the first anti-EGFr antibody shown to significantly improve progression-free survival in patients with metastatic colorectal cancer. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix. Vectibix can be conveniently administered intravenously once every two weeks.
Epidermal growth factor receptors are proteins that play an important role in cancer cell signaling.
Another anti-EGFR familty therapy is Herceptin, specific for the related family member Her-2 for breast cancer. EGFR is widely expressing in skin, the gut and Her-2 in the heart. Such being, patients have severe reeactions to the skin and intestinal tract. In fact, it's been my research experience that herceptin patients usually die of heart failure than breast cancer.
READ THE PRODUCT LABEL I FOUND:
Dermatologic toxicities, related to Vectibix blockade of EGF binding and subsequent inhibition of EGF receptor-mediated signaling pathways, included but were not limited to dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures [ CRACKS OPENING UP]. Dermatologic toxicities were reported in 89 percent of patients treated with Vectibix and were severe in 12 percent of patients. Severe dermatologic toxicities were complicated by infection, including sepsis, septic death, and abscesses requiring incisions and drainage. Vectibix may need to be withheld or discontinued for severe dermatologic toxicities.
Amgen NASDAQ: AMGN finished up today about 2% to 72.14.
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