A roundup of FDA oncology news from September 2013

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After winning accelerated approval from the U.S. FDA (FDA), Perjeta (pertuzumab) has become the first FDA-approved drug for the neoadjuvant treatment of breast cancer. The recombinant humanized monoclonal antibody was first approved in 2012 for the treatment of metastatic HER2-positive breast cancer.

Specifically, Perjeta's new use is intended for persons with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (tumor greater than 2 cm in diameter or with positive lymph nodes) who are at high risk for cancer recurrence or metastasis, or at high risk for death from the disease. It is to be used in combination with trastuzumab and other chemotherapy prior to surgery and may be followed by chemotherapy after surgery, depending on the treatment regimen used. Patients should continue to receive trastuzumab following surgery to complete 1 year of treatment.

The approved uses of another drug for breast cancer, Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension, albumin-bound), have been expanded by the FDA to include the treatment of persons with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine (Gemzar®).

Approved in 2005 as a breast cancer therapy and in 2012 for the treatment of non–small-cell lung cancer, Abraxane is a microtubule agent that can stop the growth and metastasis of cancer cells. It was evaluated under the FDA's priority review program, and has been designated an orphan drug for pancreatic cancer.

In other breast cancer therapy news, the first generic version of Xeloda (capecitabine) has gained FDA approval. Teva Pharmaceuticals USA will be permitted to market the oral chemotherapy pill in 150-mg and 500-mg strengths. The antimetabolite is a treatment for metastatic breast cancer and for metastatic colorectal cancer.

The FDA also has approved another Teva offering, Treanda Injection (bendamustine HCl), a like-named version of Treanda for Injection. The new liquid formulation removes the step of reconstituting lyophilized powder with sterile water before adding the medicine to the dilutent and administering it to the patient. This alkylating agent is indicated for use in persons who have chronic lymphocytic leukemia (CLL) or who have indolent B-cell non-Hodgkin lymphoma that has progressed during or within 6 months of treatment with rituximab (Rituxan®) or a rituximab-containing regimen. The efficacy of Treanda in CLL relative to first-line therapies other than chlorambucil has not been established.

Rituxan itself was the subject of another FDA action in September, along with Arzerra (ofatumumab). The agency approved changes to the prescribing information for these immune-suppressing and anticancer drugs in the form of a boxed warning regarding the risk of reactivation of hepatitis B virus (HBV) infection. In a person who had previous HBV infection that was clinically resolved, HBV reactivation can occur if the person later requires therapy for cancer or other conditions. A treatment that impairs the immune system can turn the previous HBV infection into an active infection. Rituxan is indicated for use as a treatment for CLL and for non-Hodgkin lymphoma, as well as for rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis. Arzerra is used in the treatment of CLL.

The FDA also announced class-wide safety labeling changes and new postmarket study requirements for all extended-release and long-acting opioid analgesics intended to treat pain. The updated indication states that these agents are to be used for the management of pain that is severe enough to require daily, 24-hour, long-term opioid treatment (not for as-needed pain relief) and for which alternative treatment options are ineffective or not tolerated.
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