FDA Updates

The US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla for injection; Genentech) for single-agent use for treating patients with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Approval for ado-trastuzumab emtansine was granted on February 22, 2013. Read More ›

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. Read More ›

The US Food and Drug Administration (FDA) approved doxorubicin hydrochloride liposome injection (Sun Pharma Global FZE) for the treatment of patients with ovarian cancer with disease progression after platinum-based chemotherapy and for the treatment of AIDS-related sarcoma in patients after failure of systemic chemotherapy or intolerance to that therapy. Read More ›

October is National Breast Cancer Awareness Month. The October 1, 2012, presidential proclamation acknowledging this points out that “Breast cancer touches the lives of Americans from every background and in every community across our Nation.” Read More ›

The US Food and Drug Administration (FDA) approved regorafenib (Stivarga, Bayer HealthCare Pharmaceuticals, Inc.) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemo­therapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. Regorafenib approval was granted on September 27, 2012. Read More ›

The US Food and Drug Administration (FDA) has approved omacetaxine mepesuccinate subcutaneous injection (Synribo, Teva Pharmaceutical Industries) for the treatment of adult patients with chronic myeloid leukemia (CML) with resistance and/or intolerance to 2 or more tyrosine kinase inhibitors (TKIs). Read More ›

The US Food and Drug Administration (FDA) approved bosutinib tablets (Bosulif; Pfizer) for the treatment of adults with chronic, accelerated, or blast phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML) who did not respond or were resistant to prior therapy.

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The FDA granted expedited approval for enzalutamide (Xtandi; Medivation and Astellas Pharma US) on August 31, 2012. Enzalutamide was approved for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have previously received docetaxel.

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On July 20, 2012, the FDA granted accelerated approval to carfilzomib injection (Kyprolis; Onyx Pharmaceuticals) for the treatment of patients with multiple myeloma who have received at least 2 prior therapies, including bortez­omib and an immunomodulatory agent, and who have demonstrated disease progression on or within 60 days of the completion of their last therapy.

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On August 3, 2012, the US Food and Drug Administration (FDA) approved ziv-aflibercept (Zaltrap, Sanofi US Inc) for use in combination with FOLFIRI (5-fluorouracil, leuco - vorin, and irinotecan) for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing chemotherapy regimen. Ziv-aflibercept, which was previously known as aflibercept, is an angiogenesis inhibitor that inhibits the blood supply to tumors.

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