News Continued from page 268
New drug and biological product approvals, 2013
F
DA in 2013 approved a total of 12 biologics licensing applications and 29 new drug applications for new medications, vaccines, and blood-derived products. Brief highlights of some of the approved medications appear below. A full list of new products and their indications appears on page 272. Breakthrough therapies. Last year marked FDA’s approval of three so-called breakthrough therapies that underwent expedited review by the agency: ibrutinib, obinutuzumab, and sofosbuvir. Manufacturers can request breakthrough therapy designation for products that target serious or life-threatening illness and are expected, on the basis of preliminary clinical evidence, to offer substantial benefits over existing treatments. The breakthrough therapy program was mandated in the Food and Drug Administration Safety and Innovation Act of 2012. Obinutuzumab, an anti-CD20 monoclonal antibody, in November became FDA’s first breakthrough therapy approval. The biologic is indicated, in combination with chlorambucil, for the treatment of chronic lymphocytic leukemia (CLL) in patients who have not previously received drug therapy for the disease. According to FDA, patients with CLL who were treated with obinutuzumab and chlorambucil lived an average of 23 months without disease progression, compared with 11 months in those treated with chlorambucil alone. Also approved in November was ibrutinib, a Bruton tyrosine kinase inhibitor indicated for the treatment of mantle cell lymphoma, a non-Hodgkin lymphoma that primarily affects older adults. In a preliminary study, ibrutinib was found to produce a 68% response rate in patients with relapsed or refractory mantle cell lymphoma. It is not yet known whether the drug extends patients’ lives or prevents disease-related symptoms. Sofosbuvir was approved in December for the treatment of chronic hepatitis
270
C infection. The oral therapy is the first hepatitis C treatment that has been shown to eradicate specific subtypes of the virus without coadministration of an interferon. According to FDA, manufacturers through last December had applied for the breakthrough therapy designation for 128 drugs and biologics, and the agency had approved the designation for 37 of those products. Melanoma. Two oral agents from GlaxoSmithKline were approved in May as monotherapy in patients with unresectable or metastatic melanoma. Dabrafenib is indicated in patients whose tumors have the BRAF V600E mutation. Trametinib is indicated in patients with the BRAF V600E or V600K mutation. The drug is the first FDA-approved mitogen-activated protein kinase kinase inhibitor.
FDA in March approved the targeted receptor-mapping agent technetium Tc 99m tilmanocept injection to help clinicians identify lymph nodes that drain tumor sites in patients with melanoma or breast cancer. The radiopharmaceutical is the first new FDA-approved drug for use in lymphatic mapping since 1981, when isosulfan blue became available. Other firsts. Other drug-related firsts in 2013 included the approval in December of fluticasone furoate– vilanterol inhalation powder, the first once-daily inhaled therapy for chronic obstructive pulmonary disease that contains a long-acting b2-adrenergic agonist and a corticosteroid. FDA in January approved the first recombinant influenza vaccine and mipomersen sodium, the first antisense therapy. —Kate Traynor DOI 10.2146/news140015
Hospitals’ performance at medication communication improved, VBP data suggest
T
he most recent public data related to the Hospital Value-Based Purchasing (VBP) Program suggest that hospitals are doing a better job at always telling inpatients about their new medications. For the fiscal year 2014 program, 70.7% of participating hospitals met or surpassed the achievement threshold for the measure “communication about medicines.” This measure is a composite of two items in the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient survey:
Am J Health-Syst Pharm—Vol 71 Feb 15, 2014
• Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? • Before giving you any new medicine, how often did hospital staff describe possible side effects in a way you could understand?
The Centers for Medicare and Medicaid Services (CMS) set the achievement threshold for this measure at 59.85% for the fiscal year 2014 VBP program. Continued on page 274
Copyright of American Journal of Health-System Pharmacy is the property of American Society of Health System Pharmacists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
New drug and biological product approvals, 2013
F
DA in 2013 approved a total of 12 biologics licensing applications and 29 new drug applications for new medications, vaccines, and blood-derived products. Brief highlights of some of the approved medications appear below. A full list of new products and their indications appears on page 272. Breakthrough therapies. Last year marked FDA’s approval of three so-called breakthrough therapies that underwent expedited review by the agency: ibrutinib, obinutuzumab, and sofosbuvir. Manufacturers can request breakthrough therapy designation for products that target serious or life-threatening illness and are expected, on the basis of preliminary clinical evidence, to offer substantial benefits over existing treatments. The breakthrough therapy program was mandated in the Food and Drug Administration Safety and Innovation Act of 2012. Obinutuzumab, an anti-CD20 monoclonal antibody, in November became FDA’s first breakthrough therapy approval. The biologic is indicated, in combination with chlorambucil, for the treatment of chronic lymphocytic leukemia (CLL) in patients who have not previously received drug therapy for the disease. According to FDA, patients with CLL who were treated with obinutuzumab and chlorambucil lived an average of 23 months without disease progression, compared with 11 months in those treated with chlorambucil alone. Also approved in November was ibrutinib, a Bruton tyrosine kinase inhibitor indicated for the treatment of mantle cell lymphoma, a non-Hodgkin lymphoma that primarily affects older adults. In a preliminary study, ibrutinib was found to produce a 68% response rate in patients with relapsed or refractory mantle cell lymphoma. It is not yet known whether the drug extends patients’ lives or prevents disease-related symptoms. Sofosbuvir was approved in December for the treatment of chronic hepatitis
270
C infection. The oral therapy is the first hepatitis C treatment that has been shown to eradicate specific subtypes of the virus without coadministration of an interferon. According to FDA, manufacturers through last December had applied for the breakthrough therapy designation for 128 drugs and biologics, and the agency had approved the designation for 37 of those products. Melanoma. Two oral agents from GlaxoSmithKline were approved in May as monotherapy in patients with unresectable or metastatic melanoma. Dabrafenib is indicated in patients whose tumors have the BRAF V600E mutation. Trametinib is indicated in patients with the BRAF V600E or V600K mutation. The drug is the first FDA-approved mitogen-activated protein kinase kinase inhibitor.
FDA in March approved the targeted receptor-mapping agent technetium Tc 99m tilmanocept injection to help clinicians identify lymph nodes that drain tumor sites in patients with melanoma or breast cancer. The radiopharmaceutical is the first new FDA-approved drug for use in lymphatic mapping since 1981, when isosulfan blue became available. Other firsts. Other drug-related firsts in 2013 included the approval in December of fluticasone furoate– vilanterol inhalation powder, the first once-daily inhaled therapy for chronic obstructive pulmonary disease that contains a long-acting b2-adrenergic agonist and a corticosteroid. FDA in January approved the first recombinant influenza vaccine and mipomersen sodium, the first antisense therapy. —Kate Traynor DOI 10.2146/news140015
Hospitals’ performance at medication communication improved, VBP data suggest
T
he most recent public data related to the Hospital Value-Based Purchasing (VBP) Program suggest that hospitals are doing a better job at always telling inpatients about their new medications. For the fiscal year 2014 program, 70.7% of participating hospitals met or surpassed the achievement threshold for the measure “communication about medicines.” This measure is a composite of two items in the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient survey:
Am J Health-Syst Pharm—Vol 71 Feb 15, 2014
• Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? • Before giving you any new medicine, how often did hospital staff describe possible side effects in a way you could understand?
The Centers for Medicare and Medicaid Services (CMS) set the achievement threshold for this measure at 59.85% for the fiscal year 2014 VBP program. Continued on page 274
Copyright of American Journal of Health-System Pharmacy is the property of American Society of Health System Pharmacists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
