FDA Approvals, News & Updates

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.

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.

The FDA issued a statement warning physicians of changes in the package insert for bevacizumab (Avastin, Genentech) regarding newly identified risks.

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 brentuximab vedotin (Adcetris; Seattle Genetics) to treat Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL).

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 vemurafenib (Zelboraf, Genentech, a member of the Roche Group) for metastatic or unresectable melanoma. Vemurafenib, a BRAF inhibitor, is able to block the function of the V600E-mutated BRAF protein.

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