FDA Approvals, News & Updates

First Anti–PD-1 Immunotherapy, Pembrolizumab, Receives Accelerated FDA Approval for Advanced Melanoma;
Ibrutinib Received Expanded Indication for Patients with CLL and 17p Deletion;
FDA Approved Idelalisib for Three Types of Hematologic Cancers;
Belinostat Approved for Peripheral T-Cell Lymphoma, an Aggressive Form of NHL;
Lymphoseek Injection Received Expanded Indication for Head and Neck Cancer SLN Biopsy
The following briefs provide updates on new FDA approvals and indications to help hematology and oncology pharmacists keep up with new information regarding drugs that are coming to market for the management of patients with cancer.
The US Food and Drug Administration (FDA) approved many new cancer drugs and several new indications for previously approved drugs in 2013, as well as the first 2 drugs designated as “breakthrough therapy.”
For years, the cancer research community has pushed for the use of surrogate end points in clinical trials as a means of hastening the drug approval process.
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.
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. Approval for doxorubicin hydrochloride liposome injection was granted on February 4, 2013.
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 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.
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