Stay Up to Date
Breaking News,
Updates, & More
Click Here to
Subscribe

Bevacizumab for Metastatic Colorectal Cancer

TOP - February 2013 VOL 6, NO 1 published on March 4, 2013 in FDA Approvals

Bevacizumab (Avastin; Genentech) received FDA approval on January 23, 2013, for use in combination with fluoropyrimidine-irinotecan–based or fluoropyrimidine-oxaliplatin–based chemotherapy for treating patients with metastatic colorectal cancer (mCRC) with disease that has progressed on a regimen containing first-line bevacizumab.

The FDA approval was granted based on the results of a randomized, open-label, multinational clinical trial that enrolled patients with mCRC whose disease progressed during or within 3 months of discontinuation of first-line bevacizumab-based combination chemotherapy. The 820 patients accrued for the trial were randomized to receive chemotherapy alone or chemotherapy in combination with bevacizumab. Depending on their prior treatment, patients received either fluoropyrimidine-irinotecan–based or fluoropyrimidine-oxaliplatin–based chemotherapy, with treatment cycles for both groups repeated every 2 or 3 weeks. For those patients in the chemotherapy plus bevacizumab arm, bevacizumab was administered by intravenous infusion at a dose of 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks. Patients received bevacizumab until disease progression or unacceptable toxicity.
Overall survival (OS) was the primary end point, with a statistically significant improvement in OS observed in patients who received chemotherapy plus bevacizumab compared with those who received chemotherapy alone. Median OS was 11.2 months for patients in the chemotherapy plus bevacizumab arm and 9.8 months for patients in the chemotherapy-alone arm.

Sources
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm338433.htm
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm336763.htm

Related Items
Keytruda Approved for Patients with Previously Treated Metastatic Small-Cell Lung Cancer
Yvette Florio Lane
Web Exclusives published on June 26, 2019 in FDA Approvals, In the News
First Chemoimmunotherapy Regimen Granted Accelerated Approval for Patients with Previously Treated DLBCL
Yvette Florio Lane
Web Exclusives published on June 12, 2019 in FDA Approvals, In the News
Welcome to the Fourth Annual Oncology Guide to New FDA Approvals
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals
New Indications Approved by the FDA in 2018 for Oncology Drugs
Dalia Buffery, MA, ABD
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals
FDA Approvals of Novel Brand-Name Prescription Cancer Drugs in 2018
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals
Braftovi (Encorafenib) plus Mektovi (Binimetinib) Third BRAF/MEK Inhibition Combination Approved for Metastatic Melanoma with BRAF Mutation
Lisa A. Raedler, PhD, RPh, Medical Writer
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals, Melanoma
Copiktra (Duvelisib) Approved for Relapsed or Refractory CLL, SLL, and Follicular Lymphoma
Lisa A. Raedler, PhD, RPh, Medical Writer
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals, Lymphoma
Daurismo (Glasdegib) Approved, in Combination with Low-Dose Cytarabine, for Newly Diagnosed Acute Myeloid Leukemia in Older Adults or Those Unfit for Intensive Chemotherapy
Loretta Fala, Medical Writer
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals, Leukemia
Erleada (Apalutamide) First Drug Approved by the FDA for Nonmetastatic Castration-Resistant Prostate Cancer
Loretta Fala, Medical Writer
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals, Prostate Cancer
Imbruvica (Ibrutinib) plus Rituxan (Rituximab) New Combination Approved for the Treatment of Waldenström’s Macroglobulinemia
Lisa A. Raedler, PhD, RPh, Medical Writer
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals, Lymphoma
Last modified: May 21, 2015