FDA Approvals

APP Pharmaceuticals has issued a voluntary recall of 5 lots of irinotecan hydrochloride injection (Camptosar) as a precautionary measure. No adverse events related to the recalled products have been reported. The following lots have been recalled:

The US Food and Drug Administration (FDA) has approved Inform Dual ISH (Ventana Medical Systems), a genetic test that allows for measurement of the number of copies of the HER2 gene in tumor tissue. This method of identification of women with breast cancer who are HER2+ pinpoints who is, and who is not, a candidate for Herceptin (trastuzumab).

 

The US Food and Drug Administration (FDA) has approved a short-acting formulation of oxycodone (Oxecta, Pfizer) that uses “Aversion” technology to stop potential abusers from crushing, chewing, snorting, or injecting the drug. Oral abuse remains possible. In addition, Pfizer acknowledged that the potential to abuse the drug through all routes is feasible.

 

The drug is indicated for acute and chronic moderate-to-severe pain.

The US Food and Drug Administration (FDA) has approved a 45 mg for 6-month administration formulation of leuprolide acetate for depot suspension (Lupron Depot, Abbott) for palliative treatment of advanced prostate cancer. This dosing option adds to the existing formulations, which are injected every 1 month, 3 months, and 4 months.

 

This past Friday, the US Food and Drug Administration (FDA) approved 2 drugs that could help our patients: fentanyl nasal spray (Lazanda, Archimedes Pharma) and rivaroxaban (Xarelto, Janssen Pharmaceuticals).

 

The US Food and Drug Administration (FDA) has approved brentuximab vedotin (Adcetris; Seattle Genetics) to treat Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL).

With brentuximab, an antibody-drug conjugate, the antibody directs the drug to the target CD30. The agent is to be used in patients with HL whose disease has progressed after autologous stem-cell transplant or, for those who cannot receive a transplant, after 2 lines of chemotherapy. Brentuximab also may be used in patients with ALCL whose disease has progressed after 1 line of chemotherapy.

The FDA has approved crizotinib (Xalkori; Pfizer) to treat patients with locally advanced or metastatic non–small-cell lung cancer (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene. Crizotinib has been approved with a companion diagnostic test that will help determine if a patient has the abnormal ALK gene, Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular).

Crizotinib blocks protein kinases, including the protein produced by abnormal ALK. This oral agent is designed to be taken twice daily as a single-agent treatment.

The FDA has issued 510(k) clearance to market HE4 Test in an algorithm (ROMA [HE4 EIA + ARCHITECT CA 125 II]; Fujirebio Diagnostics), which aids in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery.

This Risk of Ovarian Malignancy Algorithm test uses the results from CA 125 and HE4 blood tests to identify patients presenting with adnexal mass as high or low likelihood for finding malignancy on surgery.

The US Food and Drug Administration (FDA) has approved denosumab (Prolia, Amgen) to increase bone mass in patients at high risk for fracture receiving androgen- deprivation therapy for nonmetastatic prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer. This monoclonal antibody that binds to RANKL was approved based on results of 2 randomized, double-blind, placebo-controlled trials. One trial randomized 1468 men with prostate cancer.

The FDA has granted 510k marketing clearance to an invitro diagnostic assay (NADiA ProsVue, Iris International) for determining rate of change of serum total prostate-specific antigen over a period of time. A slope of 3 assays is indicated for use as a prognostic marker in conjunction with clinical evaluation to aid in identifying those patients at reduced risk for recurrence of prostate cancer for the 8-year period following prostatectomy.

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