BREAKING NEWS Newest vaccine has arrived in Minnesota: 'Everyone who has the opportunity to get this shot should take it' Full Story

FDA approves new option for cancer patients

Vitrakvi is the first medication developed specifically to target tumors based on gene mutations, not their location in the body.

Posted: Nov 29, 2018 9:24 AM
Updated: Nov 29, 2018 9:44 AM

The US Food and Drug Administration approved two cancer treatments, Vitrakvi and Xospata, this week after expedited reviews.

Vitrakvi, approved Monday, is "a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker)."

The FDA said in a statement that it is the second approved cancer treatment that is based on a tumor biomarker instead of the place in the body where the tumor originated.

Vitrakvi will be used for the treatment of solid tumors that have an NTRK (neurotrophic receptor tyrosine kinase) gene fusion that do not have a known resistance mutation, that are not metastatic or where surgical removal is likely to lead to severe morbidity, and that have no alternative treatments or have progressed after treatments.

NTRK genes are rare but occur in many types of cancer, the FDA said, such as mammary analogue secretory carcinoma and infantile fibrosarcoma.

Xospata tablets, approved Wednesday, are for the "treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation," according to the FDA.

Alongside the tablets, the agency also approved a diagnostic to detect the mutation.

"Approximately 25 to 30 percent of patients with AML have a mutation in the FLT3 gene. These mutations are associated with a particularly aggressive form of the disease and a higher risk of relapse," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence, said in the statement.

AML is a rapidly progressing cancer that affects the numbers of normal blood cells and calls for continuous transfusions, the FDA said.

Both treatments were granted Priority Review designation.

Priority Review, established in 1992, means the FDA aims to review the drug or treatment within six months, opposed to 10 months for a standard review.

"A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications," the FDA says.

Both treatments also received orphan drug designation, a status granted to drugs for rare diseases or conditions.

Minnesota Coronavirus Cases

Data is updated nightly.

Cases: 485655

Reported Deaths: 6558
CountyCasesDeaths
Hennepin1007641586
Ramsey43106801
Dakota36297390
Anoka33293385
Washington22078256
Stearns18734201
St. Louis14805262
Scott13290107
Wright12526115
Olmsted1178988
Sherburne872872
Carver772640
Clay691587
Rice670491
Blue Earth594735
Kandiyohi579574
Crow Wing520681
Chisago499045
Otter Tail482170
Benton446490
Winona418349
Mower404731
Douglas392668
Nobles387047
Goodhue385768
Polk343162
McLeod339349
Beltrami337951
Morrison324547
Itasca313046
Lyon313044
Becker311342
Isanti306154
Steele300411
Carlton300149
Pine282016
Freeborn280723
Nicollet258641
Todd248030
Brown245037
Le Sueur235320
Mille Lacs227447
Cass220024
Waseca208717
Meeker207434
Martin189528
Wabasha18653
Roseau180217
Hubbard160640
Houston157314
Dodge15224
Renville149640
Redwood147027
Fillmore13728
Chippewa136335
Cottonwood134820
Pennington134416
Wadena130920
Faribault123017
Aitkin118833
Sibley117310
Watonwan11738
Rock115714
Kanabec107519
Pipestone101424
Yellow Medicine97617
Murray9448
Jackson93510
Swift87918
Pope8045
Marshall77815
Stevens7418
Lake74018
Clearwater71914
Lac qui Parle68416
Wilkin67110
Koochiching61811
Big Stone5163
Lincoln5062
Grant4918
Norman4788
Unassigned46768
Mahnomen4417
Kittson40921
Red Lake3625
Traverse3055
Lake of the Woods2191
Cook1180

Iowa Coronavirus Cases

Data is updated nightly.

Cases: 362827

Reported Deaths: 5440
CountyCasesDeaths
Polk58260551
Linn20670313
Scott18318210
Black Hawk16258292
Woodbury14979211
Johnson1384874
Dubuque13562194
Dallas1138690
Pottawattamie10791143
Story1024945
Warren556674
Clinton543784
Cerro Gordo533782
Webster519587
Marshall497272
Sioux494869
Buena Vista474537
Des Moines458861
Muscatine452291
Wapello4345108
Jasper417766
Plymouth395378
Lee375452
Marion359169
Jones294154
Henry293337
Carroll286249
Bremer280854
Crawford275135
Boone259730
Washington254347
Benton253854
Mahaska224746
Jackson221638
Dickinson217840
Tama213765
Kossuth208555
Clay193625
Hamilton192142
Delaware189140
Winneshiek189127
Buchanan185729
Fayette185235
Page183319
Hardin181439
Wright179931
Harrison179469
Cedar178523
Clayton168154
Butler167231
Mills163020
Floyd162741
Cherokee154836
Madison154718
Poweshiek154330
Hancock147130
Allamakee146747
Lyon145941
Iowa145023
Appanoose139247
Grundy139230
Jefferson138734
Winnebago138631
Cass134751
Calhoun133811
Mitchell130940
Louisa128241
Union126631
Chickasaw125215
Sac124618
Emmet121740
Shelby121733
Franklin118319
Humboldt117925
Guthrie116628
Palo Alto105221
Montgomery104136
Howard102921
Clarke100420
Unassigned9900
Keokuk98229
Monroe93328
Adair92128
Ida91432
Pocahontas85419
Davis83123
Monona81627
Greene77510
Lucas74021
Osceola70615
Worth6997
Taylor66612
Fremont5909
Decatur5829
Van Buren56118
Ringgold52320
Wayne48921
Audubon4889
Adams3274
Rochester/St. Mary'S
Clear
49° wxIcon
Hi: 49° Lo: 26°
Feels Like: 46°
Mason City
Clear
50° wxIcon
Hi: 52° Lo: 29°
Feels Like: 50°
Albert Lea
Partly Cloudy
45° wxIcon
Hi: 46° Lo: 28°
Feels Like: 45°
Austin
Partly Cloudy
45° wxIcon
Hi: 46° Lo: 27°
Feels Like: 45°
Charles City
Partly Cloudy
48° wxIcon
Hi: 51° Lo: 27°
Feels Like: 48°
Several days of mild weather expected
KIMT Radar
KIMT Eye in the sky

Community Events