Healthcare Industry News: fluoropyrimidine
News Release - January 21, 2010
Amgen Presents Complete Results From Two Pivotal Phase 3 Studies of Vectibix(R) at Gastrointestinal Cancers SymposiumTHOUSAND OAKS, Calif., Jan. 21 (Healthcare Sales & Marketing Network) -- Amgen (Nasdaq: AMGN) today announced that detailed results from two pivotal Phase 3 studies evaluating Vectibix® (panitumumab) in combination with chemotherapy for the first and second-line treatment of metastatic colorectal cancer (mCRC) (the PRIME '203' and '181' trials, respectively) will be presented at the 2010 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in Orlando, Florida from Jan. 22-24, 2010.
"The results from the 203 and 181 trials evaluating Vectibix administered in combination with chemotherapy in first and second-line treatment provide important information for patients with metastatic colorectal cancer and the physicians who care for them," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Our data reinforce the importance of the KRAS mutation as a predictive biomarker for responsiveness to Vectibix therapy. We believe that KRAS testing should be conducted in all patients with colorectal cancer soon after diagnosis, to allow physicians to choose the most appropriate treatment strategies for their patients."
Full data from these two pivotal Phase 3 studies will be presented on Sunday, January 24, at 10:30 a.m. (EST). Identified below are selected abstracts of interest. Updated data will be presented at the meeting.
SELECTED ABSTRACTS OF INTEREST
- Randomized phase 3 study of panitumumab (pmab) with FOLFIRI vs FOLFIRI alone as 2nd-line treatment (tx) in patients (pts) with metastatic colorectal cancer (mCRC): Patient reported outcomes (PRO)
Lead Author: Peeters M
Abstract No. 282 (Sunday, Jan. 24, 2010, 10:30 a.m.-12:00 p.m.)
- Randomized phase 3 study of panitumumab (pmab) with FOLFOX4 compared to FOLFOX4 alone as first-line treatment (tx) for metastatic colorectal cancer (mCRC): PRIME trial
Lead Author: Siena S
Abstract No. 283 (Sunday, Jan. 24, 2010, 10:30 a.m.-12:00 p.m.)
- Primary analysis of a phase II study (20060314) combining first line panitumumab (pmab) with FOLFIRI in the treatment of patients (pts) with metastatic colorectal cancer (mCRC)
Lead Author: Koehne C-H
Abstract No. 414 (Sunday, Jan. 24, 2010, 7:00-8:00 a.m., 12:00-1:00 p.m.)
- Epidermal-growth factor receptor (EGFR) inhibitor-related skin toxicity: review of primary analysis data from a phase II study (20060314) of panitumumab (pmab) with FOLFIRI in the first line treatment of metastatic colorectal cancer (mCRC)
Lead Author: Karthaus M
Abstract No. 429 (Sunday, Jan. 24, 2010, 7:00-8:00 a.m., 12:00-1:00 p.m.)
Vectibix is the first fully human anti-EGFR antibody approved by the United States (U.S.) Food and Drug Administration (FDA) for the treatment of mCRC. Vectibix was approved in the U. S. in September 2006 as monotherapy for the treatment of patients with EGFRexpressing metastatic colorectal carcinoma after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
The effectiveness of Vectibix as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix. Retrospective subset analyses of metastatic colorectal cancer trials have not shown a treatment benefit for Vectibix in patients whose tumors had KRAS mutations in codon 12 or 13. Use of Vectibix is not recommended for the treatment of colorectal cancer with these mutations.
In December 2007, the European Medicines Agency (EMA) granted a conditional marketing authorization for Vectibix as monotherapy for the treatment of patients with EGFR expressing metastatic colorectal carcinoma with non-mutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. Vectibix has been launched in over 20 EU countries, Russia, Switzerland, Australia and Canada. Applications in the rest of the world are pending.
Important Product Safety Information
Dermatologic Toxicity: Dermatologic toxicities occurred in 89 percent of patients and were severe (NCI-CTC grade 3 and higher) in 12 percent of patients receiving Vectibix monotherapy. Withhold Vectibix for dermatologic toxicities that are grade 3 or higher or are considered intolerable. If toxicity does not improve to less than or equal to grade 2 within 1 month, permanently discontinue Vectibix. The clinical manifestations included, but were not limited to, dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Subsequent to the development of severe dermatologic toxicities, infectious complications, including sepsis, septic death, and abscesses requiring incisions and drainage were reported.
Infusion Reactions: Severe infusion reactions occurred in approximately 1 percent of patients. Severe infusion reactions included anaphylactic reactions, bronchospasm, and hypotension. Although not reported with Vectibix, fatal infusion reactions have occurred with other monoclonal antibody products. Stop infusion if a severe infusion reaction occurs. Depending on the severity and/or persistence of the reaction, permanently discontinue Vectibix.
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
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