Cancer Drugs and Indications Newly Approved

June 2, 2007

Anastrozole (Arimidex): Conversion to regular approval for the adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. Issued September 2005.Bevacizumab (Avastin): Treatment of metastatic colon cancer. Issued June 2006. Bortezomib (Velcade): Treatment of previously treated mantle cell lymphoma. Issued December 2006. Capecitabine (Xeloda): Single-agent adjuvant treatment of Dukes’ stage C colon cancer in patients who have undergone complete resection of the primary tumor and for whom fluoropyrimidine therapy alone would be preferred. Issued June 2005. Cetuximab (Erbitux): For use in combination with radiation therapy for the treatment of patients with unresectable squamous cell cancer of the head and neck and for patients whose disease has metastasized despite use of standard chemotherapy. Issued March 2006. Dasatinib (Sprycel): Treatment of chronic myelogenous leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia. Issued June 2006. Decitabine (Dacogen): Treatment of myelodysplastic syndromes. Issued May 2006. Docetaxel (Taxotere): In combination with cisplatin and fluorouracil prior to radiotherapy for treatment of inoperable locally advanced squamous cell carcinoma of the head and neck. Issued October 2006. Erlotinib (Tarceva): Treatment of locally advanced or metastatic non–small-cell lung cancer following failure of at least one prior chemotherapy regimen. Issued November 2004; In combination with gemcitabine for first-line treatment of locally advanced, unresectable, or metastatic pancreatic cancer. Approved for this indication November 2005. Exemestane (Aromasin): Adjuvant treatment of postmenopausal women with estrogen receptor positive early breast cancer who have received 2 or 3 years of tamoxifen therapy and are switched to exemestane for completion of 5 years of adjuvant hormonal therapy. Issued October 2005.Gefitinib (Iressa): AstraZeneca and FDA approved new labeling for gefitinib limiting its use to cancer patients who are currently benefiting or have previously benefited from treatment with this agent. Distribution limited under a risk-management plan called Iressa Access Program. Issued June 2005.Gemcitabine (Gemzar): In combination with carboplatin for treatment of ovarian cancer. Issued July 2006.Lapatinib (Tykerb): Treatment in combination with capecitabine of advanced or metastatic breast cancer (HER2-positive). Issued March 2007.Lenalidomide (Revlimid): Treatment of patients with deletion 5q cytogenetic abnormality subtype of myelodysplastic syndrome. Issued December 2005. Treatment of multiple myeloma. June 2006.Letrozole (Femara): Adjuvant treatment of postmenopausal women with hormone-receptor-positive early breast cancer. Issued January 2006.Nelarabine (Arranon): Accelerated approval for the treatment of refractory or relapsed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. Patients must have had failure of at least two prior chemotherapy regimens. Issued October 2005.Panitumumab (Vectibix): Treatment of colorectal cancer that has metastasized following standard chemotherapy. Issued September 2006. Pegaspargase (Oncaspar): Treatment of acute lymphoblastic leukemia in adults and children. Issued July 2006. Rituximab (Rituxan): First-line treatment of diffuse large B-cell, CD20 positive, non-Hodgkin’s lymphoma in combination with CHOP or other anthracycline-based chemotherapy regimens. Issued February 2006. Sorafenib (Nexavar): Treatment of advanced renal cell carcinoma in adults. Issued December 2005.Sunitinib maleate (Sutent): Treatment of gastrointestinal stromal tumor (GIST) after disease progression or intolerance to imatinib mesylate (Gleevec). Also accelerated approval for the treatment of advanced renal cell carcinoma based on partial response rates and response duration. Issued January 2006. Approved for first-line treatment of advanced renal cell carcinoma. Issued February 2007.Thalidomide (Thalomid): Treatment of multiple myeloma. Issued May 2006.Topotecan (Hycamtin): Treatment of cervical cancer. Issued June 2006.Trastuzumab (Herceptin): Expanded use of trastuzumab post surgery in combination with other cancer drugs for treatment of HER-2 positive early breast cancer. Issued November 2006.Vorinostat (Zolinza): Treatment of cutaneous manifestations of progressive, recurrent cutaneous T-cell lymphoma. Issued October 2006.


Cancer Drugs and Indications Newly Approved By U.S. Food and Drug Administration, May 2005 – April 2007

Anastrozole (Arimidex): Conversion to regular approval for the adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. Issued September 2005.

Bevacizumab (Avastin): Treatment of metastatic colon cancer. Issued June 2006.

Bortezomib (Velcade): Treatment of previously treated mantle cell lymphoma. Issued December 2006.

Capecitabine (Xeloda): Single-agent adjuvant treatment of Dukes’ stage C colon cancer in patients who have undergone complete resection of the primary tumor and for whom fluoropyrimidine therapy alone would be preferred. Issued June 2005.

Cetuximab (Erbitux): For use in combination with radiation therapy for the treatment of patients with unresectable squamous cell cancer of the head and neck and for patients whose disease has metastasized despite use of standard chemotherapy. Issued March 2006.

Dasatinib (Sprycel): Treatment of chronic myelogenous leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia. Issued June 2006.

Decitabine (Dacogen): Treatment of myelodysplastic syndromes. Issued May 2006.

Docetaxel (Taxotere): In combination with cisplatin and fluorouracil prior to radiotherapy for treatment of inoperable locally advanced squamous cell carcinoma of the head and neck. Issued October 2006.

Erlotinib (Tarceva): Treatment of locally advanced or metastatic non–small-cell lung cancer following failure of at least one prior chemotherapy regimen. Issued November 2004; In combination with gemcitabine for first-line treatment of locally advanced, unresectable, or metastatic pancreatic cancer. Approved for this indication November 2005.

Exemestane (Aromasin): Adjuvant treatment of postmenopausal women with estrogen receptor positive early breast cancer who have received 2 or 3 years of tamoxifen therapy and are switched to exemestane for completion of 5 years of adjuvant hormonal therapy. Issued October 2005.

Gefitinib (Iressa): AstraZeneca and FDA approved new labeling for gefitinib limiting its use to cancer patients who are currently benefiting or have previously benefited from treatment with this agent. Distribution limited under a risk-management plan called Iressa Access Program. Issued June 2005.

Gemcitabine (Gemzar): In combination with carboplatin for treatment of ovarian cancer. Issued July 2006.

Lapatinib (Tykerb): Treatment in combination with capecitabine of advanced or metastatic breast cancer (HER2-positive). Issued March 2007.

Lenalidomide (Revlimid): Treatment of patients with deletion 5q cytogenetic abnormality subtype of myelodysplastic syndrome. Issued December 2005. Treatment of multiple myeloma. June 2006.

Letrozole (Femara): Adjuvant treatment of postmenopausal women with hormone-receptor-positive early breast cancer. Issued January 2006.

Nelarabine (Arranon): Accelerated approval for the treatment of refractory or relapsed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. Patients must have had failure of at least two prior chemotherapy regimens. Issued October 2005.

Panitumumab (Vectibix): Treatment of colorectal cancer that has metastasized following standard chemotherapy. Issued September 2006.

Pegaspargase (Oncaspar): Treatment of acute lymphoblastic leukemia in adults and children. Issued July 2006.

Rituximab (Rituxan): First-line treatment of diffuse large B-cell, CD20 positive, non-Hodgkin’s lymphoma in combination with CHOP or other anthracycline-based chemotherapy regimens. Issued February 2006.

Sorafenib (Nexavar): Treatment of advanced renal cell carcinoma in adults. Issued December 2005.

Sunitinib maleate (Sutent): Treatment of gastrointestinal stromal tumor (GIST) after disease progression or intolerance to imatinib mesylate (Gleevec). Also accelerated approval for the treatment of advanced renal cell carcinoma based on partial response rates and response duration. Issued January 2006. Approved for first-line treatment of advanced renal cell carcinoma. Issued February 2007.

Thalidomide (Thalomid): Treatment of multiple myeloma. Issued May 2006.

Topotecan (Hycamtin): Treatment of cervical cancer. Issued June 2006.

Trastuzumab (Herceptin): Expanded use of trastuzumab post surgery in combination with other cancer drugs for treatment of HER-2 positive early breast cancer. Issued November 2006.

Vorinostat (Zolinza): Treatment of cutaneous manifestations of progressive, recurrent cutaneous T-cell lymphoma. Issued October 2006.